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
Electrode, Electrocardiograph DRX
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
Oximeter DQA
Cable, Transducer And Electrode, Patient, (Including Connector) DSA
Computer, Blood-Pressure DSK
Alarm, Blood-Pressure DSJ
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
System, Measurement, Blood-Pressure, Non-Invasive DXN
Continuous Measurement Thermometer FLL
Monitor, St Segment With Alarm MLD
System, Network And Communication, Physiological Monitors MSX
Detector And Alarm, Arrhythmia DSI
Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
Adaptor, Lead Switching, Electrocardiograph DRW
Ventilator, Continuous, Facility Use CBK
Electrocardiograph, Ambulatory (Without Analysis) MWJ
Spirometer, Monitoring (W/Wo Alarm) BZK
Bilirubin (Total And Unbound) In The Neonate Test System MQM
Recorder, Paper Chart DSF
Computer, Diagnostic, Programmable DQK
Blood Pressure Cuff DXQ
Cannula, Nasal, Oxygen CAT
Display, Cathode-Ray Tube, Medical DXJ
Plethysmograph, Impedance DSB
Full-Montage Standard Electroencephalograph GWQ
Electrocardiograph DPS
Transducer, Gas Flow BXP
System, Monitoring, Perinatal HGM
Gas-Machine, Anesthesia BSZ
Recorder, Magnetic Tape, Medical DSH
Medical Device Data System OUG
Analyzer, Gas, Oxygen, Gaseous-Phase CCL
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
Monitor, Breathing Frequency BZQ
Calculator, Pulmonary Function Data BZC
Analyzer, Spectrum, Electroencephalogram Signal GWS
Stimulator, Nerve, Peripheral, Electric KOI
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
Monitor, Carbon-Dioxide, Cutaneous LKD
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
Transducer, Blood-Pressure, Extravascular DRS
Tape And Bandage, Adhesive KGX
Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
Computer, Diagnostic, Pre-Programmed, Single-Function DXG
Transmitters And Receivers, Electrocardiograph, Telephone DXH
Electrode, Circular (Spiral), Scalp And Applicator HGP
Catheter, Retention Type, Balloon EZL
Antimicrobial Blood Pressure Cuff OED
Cable, Electrode IKD
Amplifier And Signal Conditioner, Transducer Signal DRQ
Uterine Electromyographic Monitor OSP
Mixer, Breathing Gases, Anesthesia Inhalation BZR
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
Infant Heel Warmer (Chemical Heat Pack) MPO

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

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Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device