FDA Registration
Active
🇺🇸 United States
Philips North America LLC
Reg #: 3016618143
·
FEI: 3016618143
·
Expires 2026
Products
60
Proprietary Names
592
Establishment Types
3
Classifications
60
Registration Details
- Registration Name
- Philips North America LLC
- Registration Number
- 3016618143
- FEI Number
- 3016618143
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 222 Jacobs Street
- City
- Cambridge
- State
- MA
- ZIP
- 02141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090785
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2022-02-23 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2010-01-27 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2013-07-31 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2013-07-31 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2013-07-31 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2013-07-31 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2013-07-31 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2013-07-31 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2013-07-31 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2013-07-31 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2013-07-31 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2018-05-14 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2018-05-14 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2018-05-14 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2018-05-14 |
| Adaptor, Lead Switching, Electrocardiograph | DRW | Class 2 | Cardiovascular | No | 2018-05-14 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2020-09-23 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2009-03-11 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2012-01-25 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2008-04-16 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 1992-10-13 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2013-01-22 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2015-11-03 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2022-02-01 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2018-05-11 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2016-03-31 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2016-03-31 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2016-03-31 |
| Transducer, Gas Flow | BXP | Class 1 | Anesthesiology | No | 2014-09-11 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2009-10-29 |
| Gas-Machine, Anesthesia | BSZ | Class 2 | Anesthesiology | No | 2009-05-27 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2019-10-15 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2019-10-15 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2020-09-22 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2026-05-22 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2026-05-22 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2026-05-22 |
| Analyzer, Spectrum, Electroencephalogram Signal | GWS | Class 1 | Neurology | No | 2026-05-22 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2026-05-22 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2026-05-22 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2026-05-22 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2026-05-22 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2026-05-22 |
| Monitor, Carbon-Dioxide, Cutaneous | LKD | Class 2 | Anesthesiology | No | 2026-05-22 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2026-05-22 |
| Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK | Class 2 | Anesthesiology | No | 2026-05-22 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2012-03-22 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2016-01-28 |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | Class 2 | Cardiovascular | No | 2016-02-18 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2011-10-20 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2007-12-05 |
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | Class 2 | Obstetrics/Gynecology | No | 2009-02-19 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2011-06-09 |
| Antimicrobial Blood Pressure Cuff | OED | Class 2 | Cardiovascular | No | 2008-01-10 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2003-11-12 |
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2010-10-19 |
| Uterine Electromyographic Monitor | OSP | Class 2 | Obstetrics/Gynecology | No | 2022-10-12 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2020-07-23 |
| Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | DRY | Class 2 | Cardiovascular | No | 2009-02-19 |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | Class 1 | Physical Medicine | No | 2008-04-16 |
Proprietary Names
Flex Adapter
Nissha Adult Electrode
Quadtrode CV MRI ECG Electrode Pad - 989803179041
40494E, Limb Clamp Electrode
QUADTRODE MRI ECG PAD,25/BOX - 989803179031
Neonatal Quadtrode MRI ECG Electrode Pad - 989803179051
ePatch ECG Electrode
Patch ECG Electrode
MCOT Patch
Patch electrode
ePatch electrode
2-CH Patch
Universal Patch
BTP-1000P (Patch)
Patch
Philips ECG Comfort Patch
Lead Wire Adapter
Gel, ECG/EEG, Skin Prep, Tube, 3-Pack
Quick Connect SpO2 Grip, Adult, 20/box - 989803166551
Quick Connect SpO2 Grip, Ped, 20/box - 989803166561
Quick Connect SpO2 Clip, Adult - 989803166531
Quick Connect SpO2 Probe, MRI - 989803161991
Quick Connect SpO2 Clip, Pediatric - 989803166541
CAB,4 LD,NEO.MRI ECG - 9222
SpO2 SENSOR GRIP ADULT/NEONATAL 2 PACK - 989803162501
GRIP SENSOR STARTER KIT - 989803162491
SpO2 SENSOR GRIP INFANT/PEDIATRIC 2 PACK - 989803162511
PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160 - 94023
Quick Connect SpO2 Grip, Infant, 20/box - 989803166571
KIT,SAMPLE,AGENTS,3160 - 94018
Anesthetic Oxygen (O2) Sensor - 989803162051
CUFFF,CHILD,MRI,COLDER CONN - 989803169441
CAB,4 LD,MRI ECG - 9224
Quick Connect SpO2 Starter Kit - 989803167111
Quick Connect SpO2 Grip, Neo, 20/box - 989803166581
Wireless SP02 Module (Gen 2) - 989803163111
Wireless ECG Module - 989803163121
ADVANCED FILTER ECG CABLE - 989803170121
Expression MR Cuff, Disp, NEO, MRI, Size #5 - 989803170421
Expression MR Cuff, Disp, NEO, MRI Size #3 - 989803170401
CAB,4 LD,CV MRI ECG - 9223
MRI Patient Monitoring System, Mode
VM6 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temp
VM6 Monitor w/NIBP, SpO2, ECG, Continuous temp
VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display
VM4 Monitor w/NIBP, SpO2, ECG, Ptemp
VM8 Monitor w/NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display
VM8 SE w/NIBP, SpO2, ECG, IBP, Continuous temperature, 10¿ Display
VM8 SE w/ NIBP, SpO2, ECG, IBP, Continuous temperature, etCO2, 10¿ Display
989803179101 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult
989803178001 Microstream® EtCO2 Consumables CapnoLine® H O2 Infant/ Neonatal
989803183071 Microstream® EtCO2 Consumables CapnoLine® H O2
M4681A Microstream® EtCO2 Consumables CapnoLine® H O2
989803179121 Microstream® EtCO2 Consumables Filterline O2 Pediatric
989803179111 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult
989803178021 Microstream® EtCO2 Consumables Nasal FilterLine Infant/Neonatal
CANNULA,DISP,INFANT (4200F)
989803197511 6-Lead Set, Patient Use Disposable, Bedside, AAMI
989803173151 5-Lead Set, Single Patient Use Disposable,Telemetry, AAMI
989803192151 5-Lead Set, Single Patient Use Disposable, Chest, IEC
989803173121 3-Lead Set, Single Patient Use Disposable, Bedside, AAMI
989803174211 5-Lead Set, Single Patient Use Disposable,Bedside, IEC
989803174201 3-Lead Set, Single Patient Use Disposable, Bedside, IEC
989803192141 5-Lead Set, Single Patient Use Disposable, Chest, AAMI
989803173131 5-Lead Set, Single Patient Use Disposable, Bedside, AAMI
989803197521 6-Lead Set, Single Patient Use Disposable, Bedside, IEC
MX40 Release B7
Expression MR FlexTEMP System, Jacket - 989803178181
M4691A Microstream® EtCO2 Consumables CapnoLine H Infant/Neonatal
989803178011 Microstream® EtCO2 Consumables CapnoLine H Infant/Neonatal Long
M4686A Microstream® EtCO2 Consumables NIV Line
M4689A Microstream® EtCO2 Consumables CapnoLine H
M4687A Microstream® EtCO2 Consumables NIV Line
Airway, DEHUM TBG, ADU PED Zoll LoFlo 10
Cannula, CO2 ORAL, ADU, Zoll LoFlo, 10
Airway, DEHUM TBG, PED INF Zoll LoFlo10
Cannula, CO2, INF, Zoll LoFlo, 10
Cannula, O2 CO2, INF, 10, Zoll LoFlo
Cannula, O2 CO2 ORAL, PED, Zoll LoFlo 10
Airway, Adult Pediatric, Zoll LoFlo, 10
Airway, Pediatric Infant, Zoll LoFlo, 10
Cannula, CO2 Oral, PED, Zoll LoFlo, 10
Cannula, CO2, ADU, Zoll LoFlo, 10
Cannula, O2 CO2, PED, Zoll LoFlo, 10
Cannula, CO2, PED, Zoll LoFlo, 10
Cannula, O2 CO2, ADU, Zoll LoFlo, 10
Cannula, 02 CO2 Oral, ADU, Zoll LoFlo 10
DigiTrak XT Holter Recorder w/Leadwires
DL950 Holter System
M2202A Radiolucent Foam Electrode
Reusable Adult/Pediatric Airway Adapter
Airway Adapter - Single Patient Use - Adult/Pediatric
Airway Adapter - Single Patient Use - Neonatal
ADULT AIRWAY ADAPTER, QTY 1, MAQUET
CAPNOSTAT 5 Mainstream Sensor, Maquet
INTELLIVUE MX40 PATIENT MONITOR
989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele
989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele
989803199081 MX40 Adapter SpO2-only
989803171831 ECG 5 lead Grabber, AAMI, Tele
989803199101 MX40 Adapter 3L+SpO2
989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele
989803171971 CBL ECG 6 Lead Grabber, IEC+SpO2, Tele
989803199071 ECG 6 lead Grabber, IEC + SpO2, Tele
989803171871 CBL ECG 6lead Grabber, AAMI + SpO2, Tele
989803171931 ECG 5 lead Grabber, IEC, Tele
989803171961 ECG 6 lead Grabber, IEC, Tele
989803171861 ECG 6 lead Grabber, AAMI, Tele
989803171821 ECG 5 lead Snaps, AAMI, Tele
989803199091 MX40 Adapter 5L+SpO2
989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele
989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele
CareEvent
Snap Style Foam Electrode
989803101301 HI-Tack Foam Wet Gel ECG Electrode
40420A HI-Tack Foam Wet Gel ECG Electrode
M4612A Solid Gel Foam Electrode
989803192551 Clear Tape Wet Gel ECG Electrode
M4613A Solid Gel Foam Electrode
989803192931, SureSigns VS Temporal Temperature HH
989803180831, Genius 2 tympanic temperature probe
863286, SureSigns VS4 Government Bundle
13943B Solid Gel Tab Electrode, Resting ECG
Philips NM3 Respiratory Monitor w/VentAssist
NM3 Respiratory Profile Monitor
B800-500 BiliCal; 50 Pack
1037632 Bilichek (Advanced)
40477A Chemical/Thermal Paper
M3708A Chemical/Thermal Paper
M4816A Thermal Paper
M2485A Chemical/Thermal Paper
989803190381 Efficia 50mm Chemical Thermal Paper, No Gridlines
M4817A Thermal Paper
989803185271 Thermal Roll Paper, 110 mm Wide
989803138171 Defibrillator Chemical/Thermal Paper
M3707A Chemical/Thermal Paper
M2481A Chemical/Thermal Paper
M1710A Chemical/Thermal Paper
M2483A Chemical/Thermal Paper
40457C Chemical/Thermal Paper
989803138181 Defibrillator Chemical/Thermal Paper
ST80i Stress Test System w/ Printer, Lead Sets, Electrodes
989803180131, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Grabber
989803180141, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps
989803180121, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Grabber
989803180151, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Snaps
ST80i Stress Test System
Value Care Cuff Small Adult
Value Care Cuff Adult
Value Care Cuff Adult XL (extra long)
Value Care Cuff Large Adult
Value Care Cuff Pediatric
Value Care Cuff Infant
989803182921 Microstream® EtCO2 FilterLine H Set
989803182941 Microstream® EtCO2 VitaLine H Set
989803182931 Microstream® EtCO2 FilterLine H Set
989803160261 Microstream® EtCO2 VitaLine H Set Long
989803159581 Microstream® EtCO2 VitaLine H Set
989803160301 Microstream® EtCO2 Consumables Smart CapnoLine Plus Long
Expression IP5 Information Portal
Expression MR200 MRI Patient Monitoring System
NiBP Cuff, Single Lumen, Thigh - 989803182681
NiBP Cuff, Single Lumen, Infant #5, Disp - 989803183211
NiBP Cuff, Single Lumen, Infant - 989803182611
NiBP Cuff, Single Lumen, Adult-L - 989803182651
NiBP Cuff, Single Lumen, Neo #1, Disp - 989803183171
NiBP Cuff, Single Lumen, Pediatric - 989803182621
NiBP Cuff, Single Lumen, Lrg Adult-L - 989803182671
NiBP Cuff, Single Lumen, Sample Kit,Disp - 989803182591
NiBP Cuff, Single Lumen, Thigh, Disp - 989803182581
NiBP Cuff, Single Lumen, Lrg Adult - 989803182661
Expression IP5 Software Upgrade - 989803197491
NiBP Cuff, Single Lumen, Neo #4, Disp - 989803183201
NiBP Cuff, Single Lumen,Lrg Adult-L,Disp - 989803182571
NiBP Cuff, Single Lumen, Adult - 989803182641
NiBP Cuff, Single Lumen, Pediatric, Disp - 989803182521
NiBP Cuff, Single Lumen, Neo #3, Disp - 989803183191
NiBP Cuff, Single Lumen, Adult-L, Disp - 989803182551
NiBP Cuff, Single Lumen, Small Adult, Disp - 989803182531
NiBP Cuff, Single Lumen, Adult, Disp - 989803182541
NiBP Cuff, Single Lumen, Neo #2, Disp - 989803183181
Wireless SpO2 Patient Module - 989803183541
NiBP Cuff, Single Lumen, Infant, Disp - 989803182511
NiBP Cuff, Single Lumen, Lrg Adult, Disp - 989803182561
Advanced Apps ECG Cable - 989803176381
NiBP Cuff, Single Lumen, Small Adult - 989803182631
Expression MR Wireless ECG Patient Module - 989803183661
Expression MR200 New MRI Monitor Accessories - 866177
LoFlo Sample Line, Neo. Cannula, Box 20 - 989803183261
LoFlo Line, Adu Airway Adpt, Box 100 - 989803185381
LoFlo Sample Line, Adult Cannula, Box 20 - 989803183241
LoFlo Line, Ped Dvd Cannula, Box 100 - 989803185371
LoFlo Sample Line, Ped. Cannula, Box 20 - 989803183251
LoFlo Line, Adu Dvd Cannula, Box 20 - 989803183271
LoFlo Line, Adu Airway Adpt, Box 20 - 989803183291
LoFlo Line, Ped Dvd Cannula, Box 20 - 989803183281
LoFlo Line, Adu Dvd Cannula, Box 100 - 989803185361
CS770 IntelliSpace Critical Care and Anesthesia H
Airway Adapter Pediatric/Infant Nafion Capnoflex
Pediatric Nasal/Oral CO2 Cannula Capnoflex
Adult Nasal/Oral CO2 Cannula Capnoflex
Pediatric Nasal CO2/O2 Cannula Capnoflex
Infant/Neonatal Airway Adapter Kit Capnoflex
Infant Nasal CO2 Cannula Capnoflex
Cannula Nasal CO2 Only Pediatric Capnoflex
Cannula Nasal CO2 Adult Capnoflex
Sampling Line Male Luer-lok Adapter Dehumidification
Airway Adapter Adult/Pediatric Capnoflex
Cannula Nasal CO2/O2 Adult Capnoflex
Airway Adapter Adult/Pediatric Nafion Capnoflex
Sample Line Male Luer Capnoflex
Infant Nasal CO2/O2 Cannula
Cannula Oral/Nasal CO2/O2 Adult Capnoflex D
Pediatric / Adult Combined CO2/Flow Sensor Series 3
CO2/Flow Sensor Neonatal
Neonatal Flow Sensor Series 3
Pediatric/Adult Flow Sensor Series 3
Standard Size NICO Sensor
Small Size NICO Sensor
Pediatric Combined CO2/Flow Sensor Series 3
Neonatal Combined CO2/Flow Sensor Series 3
CO2/Flow Sensor Adult
Large Size NICO Sensor
CO2/Flow Sensor Pediatric
CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC - 989803170181
CBL OR 3-Lead ECG Trunk Cable, AAMI/IEC - 989803170171
13955C Neonatal/Pediatric Snap Electrode, Square
13953E Radiolucent Preattached Leadwire Electrode, Square
13953D Metallic Preattached Leadwire Electrode, Square
13952D Metallic Preattached Leadwire Electrode, Medium
13951C Neonatal/Pediatric Solid Gel Electrode
13952A Preattached Leadwire Electrode medium
13953B Preattached leadwire electrode square
13952B Preattached Leadwire electrode medium
13953A Preattached Leadwire electrode square
M4602A Reusable Abdominal Belt- 60mm Wd,1.3M Lg
M4603A Reusable Abdominal Belt- 60mm Wd, 15M LG
M4601A Reusable Leg Belt- 32mm X 15M
M2208A Disposable abdominal belts,100/cs
M1562B Reusable abdominal/leg belt- 50mm X 1.3M
Thermal Printer Kit, USB (989803205011)
MR Patient Care Portal 5000 (866162)
Philips Biosensor BX100
40493E Foam Wet Gel ECG Electrode
40493D Foam Wet Gel ECG Electrode
Expression MR ECG Leads, IEC, Neonatal - 989803193771
Expression MR ECG Leads, IEC, CV - 989803193751
Expression MR ECG Leads, AAMI, Neonatal - 989803193741
Expression MR Wireless SPO2 Patient module (Gen 3) 1-5 - 989803192771
Expression MR Universal Gating Interface - 989803195521
Expression MR400 MRI Patient Monitoring System (Model MR400)
Expression MR Wireless ECG Patient Module (Gen 3) 6-10 - 989803194341
Expression MR ECG Leads, AAMI - 989803193721
Expression MR ECG Leads, AAMI, Standard - 989803193731
Expression MR ECG Leads, IEC, Standard - 989803193761
FlexTEMP System, Sensor - 989803178171
Expression MR Wireless ECG Patient Module (Gen 3) 1-5 - 989803192761
Expression MR IBP Transducer Cable, 5ft - 989803194601
Expression MR FlexTEMP II Sensor - 989803194511
Expression MR Wireless SpO2 Patient Module (Gen 3)6-10 - 989803194331
Expression MR400 New MRI Monitor Accessories - 866428
FloTrak Elite Module wI Capnostat 5 C02 Sensor
CompuRecord System
Patient Information Center iX (PIC iX)
AirwayAdapter PED/INF Nafion 704-0026-00
CannulaNasal/Oral CO2/O2 ADU 704-0020-00
Cannula Nasal/Oral CO2 ADU 704-0017-00
AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10
Sample Line Male Luer 704-0027-00
Cannula Nasal CO2 PED 704-0012-00
Cannula Nasal CO2 Adult 7040010-00
Cannula Nasal CO2/O2 INF 704-0015-00
Cannula Nasal CO2/O2 ADU 704-0014-00
Cannula Nasal CO2/O2 PED 704-0016-00
Airway Adapter Kit PED/INF 704-0024-00
Airway, ADU-PED, SLM LoFlo, 10
CannulaNasal/Oral CO2/O2 PED 704-0022-00
Sample Line Male Luer Nafion 704-0028-00
989803148821 Radiolucent Foam Electrode
989803183311 Multi Care Cuff, Infant
989803183361Multi Care Cuff, Large Adult
989803183351 Multi Care Cuff, Adult XL
989803183321 Multi Care Cuff, Pediatric
989803183371 Multi Care Cuff, Thigh
989803183331 Multi Care Cuff, Small Adult
989803183341 Multi Care Cuff, Adult
M1572A Comfort Care Cuff, Pediatric
M1573A Comfort Care Cuff, Small Adult
M1575A Comfort Care Cuff, Large Adult
M1574A Comfort Care Cuff, Adult
M1571A Comfort Care Cuff, Infant
M1576A Comfort Care Cuff, Thigh
M1574XL Comfort Care Cuff, Adult XL
IntelliBridge System
IntelliVue MX400, MX450, MX500, MX550, Rev. R
Philips CareEvent Application Software Version B1
M1872S Neonatal Soft Single-Patient Cuff Size#4
989803167551 Neonatal Soft Single-Patient NIBP Cuffs
M1868S Neonatal Soft Single-Patient Cuff Size#2
M1866S Neonatal Soft Single-Patient Cuff Size#1
M1872B Neonatal Single-Patient Cuff Size #4
M1873S Infant Soft Single-Patient Cuff Size #5
M1866B Neonatal Single-Patient Cuff Size #1
989803167541 Neonatal Single-Patient NIBP Cuffs
M1868B Neonatal Single-Patient Cuff Size #2
M1870S Neonatal Soft Single-Patient Cuff Size#3
M1873B Infant Single-Patient Cuff Size #5
M1870B Neonatal Single-Patient Cuff Size #3
989803194641, Expression MR IBP DPT Kit, I/N, Box 20
989803194631, Expression MR IBP DPT Kit, A/P, Box 20
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
B800-11 BilEclipse, 50 Pack
IntelliVue Information Ctr iX Software
Arrhythmia Detector and Alarm
Philips SureSigns Central
Holter 1810/ 2010 SW
SureSigns VM4, VM6, VM8 Government Bundle
989803156201 Adult Disposable Metallic 3 Leadwire Electrode Set, AAMI
989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI
989803156231 Adult Disposable Radiolucent 3 Leadwire Electrode Set, IEC
989803156221 Adult Disposable Radiolucent 3 Leadwire Electrode Set, AAMI
989803156261 Adult Disposable Radiolucent 5 Leadwire Electrode Set, AAMI
989803156271 Adult Disp Radiolucent 5 Leadwire Electrode Set, IEC
989803204591 Microstream Advance Pediatric Nasal CO2 Filter Line
989803204611 Microstream Advance Adult Nasal CO2 Filter Line
989803204481 Microstream Advance Adult Nasal CO2 Filter Line
989803204561 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line
989803204621 Microstream Advance Adult Nasal CO2 Filter Line
989803204431 Microstream Advance Neonatal-Infant Nasal CO2 Filter Line
989803204601 Microstream Advance Pediatric Nasal CO2 Filter Line
989803204351 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line
989803204361 Microstream Advance Adult Oral-Nasal CO2 Filter Line
989803204631 Microstream Advance Neonatal-Infant Nasal CO2 Filter Line
989803204411 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line
989803204421 Microstream Advance Neonatal-Infant Nasal CO2 Filter Line
989803204441 Microstream Advance Neonatal-Infant Nasal CO2 Filter Line
989803204371 Microstream Advance Adult Oral-Nasal CO2 Filter Line
989803204571 Microstream Advance Adult Oral-Nasal CO2 Filter Line
989803204501 Microstream Advance Pediatric Nasal CO2 Filter Line
989803204541 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line
989803204391 Microstream Advance Adult Oral-Nasal CO2 Filter Line
989803204581 Microstream Advance Adult Nasal CO2 Filter Line
989803204401 Microstream Advance Pediatric Oral-Nasal CO2 Filter Line
989803204551 Microstream Advance Adult Oral-Nasal CO2 Filter Line
989803204491 Microstream Advance Adult Nasal CO2 Filter Line
989803204381 Microstream Advance Adult Oral-Nasal CO2 Filter Line
Philips SureSigns Vs2+
SureSigns VS2+
SureSigns VSi
transmitters and receivers, electro
989803183081 Mini NeoLead, AAMI metal lead
989803183121 NeoLead, AAMI radio lead
989803183101 989803183101
989803183141 Micro NeoLead, AAMI radio lead
Care Assist
Patient Information Center iX, 866389
Carescape CO2 - LoFlo
Respironics LoFlo Sidestream CO2 Module for Goldway
Respironics LoFlo Sidestream CO2 Module
Respironics LoFlo Sidestream CO2 Module for GE
Respironics Alice, LoFlo, C5 Sidestream Module
LoFlo Module - RoHS - Private Label
C5 LoFlo Sidestream Module
LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL
Cobranded LoFlo CO2 Sampling Cannula
LoFlo CO2 Sampling Cannula ADULT NASAL
LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL
LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL
LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL
LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL
LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL
LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL
LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL
LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL
LoFlo CO2 Sampling Cannula PEDIATRIC NASAL
Sample Line-Female Luer Connector
Cobranded LoFlo Sampling Line Kit
Cobranded LoFlo Sampling Line Kit w/Dehumidification Tubing
LoFlo SAMPLING LINE KIT
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL
LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL
LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL
LoFlo Airway Adapter Kit ADULT/PEDIATRIC
LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL
LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL
LoFlo Airway Adapter Kit INFANT/NEONATAL
LoFlo SAMPLING LINE KIT w/Dehumidification Tubing
LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL
LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL
IntelliVue MX750/MX850,Flexible Module Server FMX-4, Rev. R
989803203561 Esophageal/Rectal Temperature Probe 12 Fr, Reusable, Autoclavable
21075A Esophageal/Rectal 12 Fr Temperature Probe
21078A Skin Surface Temperature Probe
989803203571 Esophageal/Rectal Temperature Probe 10 Fr, Reusable, Autoclavable
989803203581 Skin Temperature Probe, Reusable, Autoclavable
21076A Esophageal/Rectal 10 Fr Temperature Probe
IntelliVue Information Center Softw
Philips IntelliVue Information Center iX, M3290B Software Version C0
Suresigns VSV
CapnoTrak CO2/O2 Nasal Cannula
CapnoTrak CO2 Oral Nasal Cannula
CapnoTrak O2 Delivery Extension Line
CapnoTrak CO2 Sampling Extension Line
CapnoTrak Dehumidification Tubing
CapnoTrak CO2 Nasal Cannula
SAMPLING LINE MALE LUER-LOK ADAPTER DEH
CapnoTrak Water Filter Assembly
CapnoTrak CO2/O2 Oral Nasal Cannula
Dehumidification Tubing - 1 ft.
Pediatric and Adult CO2 Airway Adapter, Reusable
Neonatal and Pediatric CO2 Airway Adapter, Reusable
Neonatal Flow and CO2 Sensor, Disposable
Proximal Flow Sensor, Neonatal
989803137631 Fetal Spiral Electrode
989803137651-DECG Reusable Leg plate Adapter Cable
PageWriter TC70 Cardiograph, TC70 (860315, 860352)
PageWriter TC50 Cardiograph, TC50 (860310, 860429, 860466)
PageWriter TC30 Cardiograph, TC30 (860306)
989803151771, 15/16/18-Lead Upgrade Kit (AAMI), Long
989803151641, 12-Lead Complete Lead Set (IEC), Standard Length
989803164281, USB Patient Data Cable, Class B
989803151781, 15/16/18-Lead Upgrade Kit (IEC), Long
989803151661, 12-Lead Complete Lead Set (IEC), Long
989803151691, 12-Lead Chest Lead Set (AAMI/IEC), Long
989803151711, 12-Lead Limb Lead Set (AAMI/IEC), Standard Length
989803151671, 12-Lead Chest Lead Set (AAMI/IEC), Standard Length
989803151751, 15/16/18-Lead Upgrade Kit (AAMI), Standard Length
989803151651, 12-Lead Complete Lead Set (AAMI), Long
989803151761, 15/16/18-Lead Upgrade Kit (IEC), Standard Length
989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length
989803151731, 12-Lead Limb Lead Set (AAMI/IEC), Long
Veridia Patient Monitoring System
M1921A Microstream® EtCO2 FilterLine H Set
Philips IntelliVue Information Center iX, M3290B Software Release C1
21096A Foley Catheter Temperature Probe 16FR
M2255A Foley Catheter Temperature Probe 14FR
21097A Foley Catheter Temperature Probe 18FR
M4555B Easy Care Cuff Adult
M4576B Gentle Care Cuff, Adult XL
M4578B Gentle Care Cuff, Large Adult XL
989803182291 Single Care Cuff, Small Adult
989803182301 Single Care Cuff, Adult
989803182311 Single Care Cuff, Adult XL
989803182321 Single Care Cuff, Large Adult
989803182281 Single Care Cuff, Pediatric
M4558B Easy Care Cuff Lrg Adult XL
M4557B Easy Care Cuff Lrg Adult
M4552B Easy Care Cuff, 1 Hose, Infant (1)
M4553B Easy Care Cuff, 1 Hose, Pediatric (1)
M4574B Gentle Care Cuff Small Adult
M4573B Gentle Care Cuff Pediatric
M4556B Easy Care Cuff Adult XL
M4577B Gentle Care Cuff Large Adult
M4554B Easy Care Cuff Sm Adult
M4572B Gentle Care Cuff Infant
M4559B Easy Care Cuff Thigh
M4575B Gentle Care Cuff Adult
IntelliVue Patient Monitor MP5, MP5T, MP5SC, SW Rev. J7
IntelliVue Patient Monitor MP2, SW Rev. J7
IntelliVue CL Respiration Pod, SW Rev. B
IntelliVue Multi-Measurement Module X2, SW Rev. J7
IntelliVue GuardianSoftware SW Rev. A2
989803179541 Mobile CL Respiration Pod Attachment
M1532A ECG Cable
M1672A ECG Cable
EEG Leadset - 989803180531
M1976A ECG Cable
M1663A ECG Trunk Cable
EEG Leadset - 989803180561
M1680A ECG Cable
M1979A ECG Cable
M1602A ECG Cable
M1626A ECG Cable
M1669A ECG Trunk Cable
M1665A ECG Trunk Cable
M1681A ECG Cable
M1673A ECG Cable
M1968A ECG Cable
M1644A ECG Cable
M1675A ECG Cable
M1624A ECG Cable
M1949A ECG Trunk Cable
M1671A ECG Cable
M1674A ECG Cable
M1978A ECG Cable
M1645A ECG Cable
M1973A ECG Cable
EEG Leadset - 989803180521
M1667A ECG Trunk Cable
M1974A ECG Cable
M1971A ECG Cable
M1678A ECG Cable
M2268A EEG Trunk Cable
M1934A EEG Leadset
CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171
M1668A ECG Trunk Cable
EEG Leadset - 989803180541
CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161
M1533A ECG Cable
CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181
989803157501, DigiTrak XT Patient Cable, Long
989803157481, DigiTrak XT Patient Cable, short
989803157491, DigiTrak XT Patient Cable, Medium
BTP-1000L-2-Lead Wire Adapter
BTP-1000A-Hybrid Patch
OMNI-TRAK 3000 SERIES
SureSigns VS Temporal Temperature HH - 989803192931
989803204451 Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line
989803204461 Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line
989803204471 Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line
989803178051 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2 Long
989803178041 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2
989803182991 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2
989803178031 Microstream® EtCO2 Consumables Smart CapnoLine® Guard
989803183001 Microstream® EtCO2 Consumables Smart CapnoLine® Guard O2 Long
Telemetry Monitoring System
CAPNOSTAT 5 Mainstream CO2 sensor
Printer Kit, Strip Chart, USB - 989803181881
Expression Information Portal
Expression Informal Portal
989803177981 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Pediatric Long
989803177961 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Adult Long
989803177971 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Pediatric
989803177951 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult
989803160271 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long
989803182981 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long,Adult
989803182971 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult
989803182951 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Pediatric
989803182961 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Adult
989803163201 Mobile CL Disposable Adult Cuff
989803163191 Mobile CL Reusable Adult Cuff
989803163181 Mobile CL Disposable Small Adult Cuff
989803163221 Mobile CL Disposable Large Adult Cuff
IntelliVue Multi-Measurement Module X2, SW Rev. H1
IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H1
IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D
Diverse Specialized Accessories and IntelliVue CL 865220 charging station
989803163211 Mobile CL Reusable Large Adult Cuff
IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A
989803163251 Mobile CL NBP Cradle Kit
989803168881 Mobile CL Transmitter Cradles
Philips ST/AR ST
IntelliSpace ECG
IntelliSpace ECG SW
989803196341 Avalon CL Fetal & Maternal Patch
MX40
989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele
989803204291 MX40 Adapter 6-Lead + Masimo SpO2
989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele
989803202391 MX40 Adapter Masimo SpO2-only
989803202381 MX40 Adapter 5-Lead + Masimo SpO2
Intellivue MX40 Patient Monitor
989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber
989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber
989803172221 ECG 5L Grabber, AAMI, SpO2, Tele
989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele
989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele
989803205391 Philips Nasal Alar SpO2 Sensor
989803205381 Philips Nasal Alar SpO2 Sensor
989803205401 Philips Nasal Alar SpO2 Sensor
989803160241 Microstream® EtCO2 Consumables Filterline Set Long
989803182911Microstream® EtCO2 Consumables Filterline Set
M1920A Microstream® EtCO2 Consumables Filterline Set
863379, SureSigns VS4 U.S. Gov NBP. SPO2
863283, SureSigns VS4 Vital Sign Monitor
21090A Esophageal/Rectal Temperature Probe 12FR
23001A Temperature Probe
23002A Reusable Bath Temperature Probe
M1837A Esophageal/Rectal Temperature Probe 9FR
21091A Skin Temperature Probe
23001B Temperature Probe
IntelliVue MMX Rev. R
IntelliVue MX100, X3, MMX Rev. R
Capnostat 5 Mainstream CO2 Sensor for Mindray Medical
Capnostat 5 Mainstream CO2 Sensor for Goldway Medical
Capnostat 5 Mainstream CO2 Sensor
Capnography Sensor, Reusable
989803204341 Microstream Advance Neonatal-Infant Intubated CO2 Filter Line
989803204301 Microstream Advance Adult-Pediatric Intubated CO2 Filter Line
989803204331 Microstream Advance Adult-Pediatric CO2 Intubated Filter Line
989803204321 Microstream Advance Adult-Pediatric Intubated CO2 Filter Line
989803204511 Microstream Advance Adult-Pediatric Intubated CO2 Filter Line
989803204521 Microstream Advance Adult-Pediatric Intubated CO2 Filter Line
989803204531 Microstream Advance Neonatal-Infant Intubated CO2 Filter Line
989803204311 Microstream Advance Neonatal-Infant Intubated CO2 Filter Line
Blood pressure monitor
Philips IntelliVue Information Center iX, M3290B Software
Heel Snuggler Infant Heel Warmer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device