FDA Registration
Active
🇺🇸 United States
SunMed Group Holdings, LLC
Reg #: 1314417
·
FEI: 1314417
·
Expires 2026
Products
131
Proprietary Names
288
Establishment Types
6
Classifications
131
Registration Details
- Registration Name
- SunMed Group Holdings, LLC
- Registration Number
- 1314417
- FEI Number
- 1314417
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2710 Northridge Dr NW Ste A
- City
- Grand Rapids
- State
- MI
- ZIP
- 49544
- Country
- US
Regulatory Submissions
- 510(k) Number
- K780456
- PMA Number
- P890057
Owner / Operator
- Firm Name
- SunMed Group Holdings, LLC dba AirLife
- Operator Number
- 10044795
- Address
- 2710 Northridge Drive NW, Suite A
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49544
- Country
- US
- Correspondent
- Rob Yamashita
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, High Frequency | LSZ | Class 3 | Unknown | No | 2023-07-18 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2018-04-05 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2018-01-17 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2024-08-09 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2024-08-09 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2018-01-17 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2023-07-18 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2018-01-18 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2018-04-05 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2020-04-10 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2018-01-30 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2018-01-17 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2018-01-18 |
| Stripper, Vein, Disposable | GAJ | Class 1 | General, Plastic Surgery | No | 2018-01-17 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2018-01-30 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2024-08-09 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2023-07-18 |
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2013-08-07 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2023-07-18 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2025-12-19 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2018-01-18 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2023-07-18 |
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 2020-01-02 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2024-08-09 |
| Respiratory Humidifier For Emergency Use | QOP | Class N | Unknown | No | 2023-07-20 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2024-04-22 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2013-08-01 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2026-01-23 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2026-01-23 |
| Calculator, Predicted Values, Pulmonary Function | BTY | Class 2 | Anesthesiology | No | 2024-04-22 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2026-01-22 |
| System, Rebreathing, Radionuclide | IYT | Class 2 | Radiology | No | 2023-07-18 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2018-04-09 |
| Tracheal Suction Set | OFS | Class 1 | Anesthesiology | No | 2023-07-20 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2023-08-08 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2023-07-18 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2024-07-22 |
| Conserver, Oxygen | NFB | Class 2 | Anesthesiology | No | 2023-07-18 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2024-04-22 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2013-08-07 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2013-08-07 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2018-01-30 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2013-08-01 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2013-08-02 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2023-07-18 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2018-01-17 |
| Cuff, Tracheal Tube, Inflatable | BSK | Class 2 | Anesthesiology | No | 2018-01-18 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2013-08-07 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2023-07-18 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2018-04-09 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2023-07-18 |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | Class 2 | Hematology | No | 2013-08-07 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2023-07-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-04-05 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2024-08-09 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2024-11-01 |
| Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | KDH | Class 2 | Gastroenterology, Urology | No | 2013-08-02 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2025-12-12 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2023-07-18 |
| Bottle, Collection And Trap, Breathing System (Uncalibrated) | CBC | Class 2 | General Hospital | No | 2018-01-17 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2018-01-18 |
| Laparoscopic Contraceptive Tubal Occlusion Device | KNH | Class 3 | Obstetrics/Gynecology | No | 2017-03-24 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2018-01-30 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2018-04-05 |
| Airway Suction Kit | OFO | Class 1 | Anesthesiology | No | 2023-07-20 |
| Holding Chambers, Direct Patient Interface | NVP | Class 2 | Anesthesiology | No | 2018-01-18 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2023-07-18 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2023-07-18 |
| Block, Bite | JXL | Class 2 | Neurology | No | 2013-08-02 |
| Cardiopulmonary Resuscitation Aid Kit | OEV | Class 2 | Anesthesiology | No | 2023-07-20 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2018-01-18 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2018-01-30 |
| Emergency Response Safety Kit | OKI | Class 2 | General, Plastic Surgery | No | 2023-07-20 |
| Stethoscope Head | BZS | Class 1 | Anesthesiology | No | 2018-04-05 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2023-07-18 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2024-07-03 |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | Class 2 | General Hospital | No | 2023-07-18 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2018-01-17 |
| Plethysmograph, Volume | JEH | Class 2 | Anesthesiology | No | 2024-04-22 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2018-04-05 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-10-19 |
| Chamber, Oxygen, Topical, Extremity | KPJ | Class 2 | General, Plastic Surgery | No | 2018-08-23 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2024-11-01 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2023-07-18 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2024-05-30 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2024-11-01 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2018-01-17 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-01-17 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2018-04-05 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2023-07-20 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2024-08-09 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-07-18 |
| Oxygen Administration Kit | OGL | Class 2 | Anesthesiology | No | 2023-07-20 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2018-04-09 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2023-07-18 |
| Bag, Urine Collecting, Ureterostomy | EXG | Class 1 | Gastroenterology, Urology | No | 2018-01-30 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2018-01-18 |
| Skin Prep Tray | OJU | Class 1 | General, Plastic Surgery | No | 2023-07-20 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2018-04-05 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2023-07-18 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2023-07-18 |
| Container, Embedding | KER | Class 1 | Pathology | No | 2023-07-18 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2025-11-19 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2023-07-18 |
| Resuscitator, Manual, Non Self-Inflating | NHK | Class 2 | Anesthesiology | No | 2018-01-30 |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | Class 2 | Anesthesiology | No | 2019-01-07 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 2023-07-18 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2025-02-26 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2018-01-30 |
| Humidifier Nebulizer Kit | OGG | Class 2 | Anesthesiology | No | 2023-07-20 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2013-08-07 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2026-01-09 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2018-01-17 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2024-04-22 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2018-09-13 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-09-04 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2018-01-30 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2023-07-18 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2018-04-05 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2018-06-07 |
| Non-Bronchoscopic Bronchoalveolar Lavage Catheter | OYI | Class 1 | Anesthesiology | No | 2024-11-01 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2023-07-18 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2018-01-17 |
| Catheter, Oximeter, Fiber-Optic | DQE | Class 2 | Cardiovascular | No | 2024-07-22 |
| Critical Care Ventilator | QOV | Class N | Unknown | No | 2023-07-20 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2018-01-17 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2018-01-30 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2013-08-02 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2018-01-30 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | Class 2 | Anesthesiology | No | 2019-10-30 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2018-01-18 |
Proprietary Names
VENTILATOR, HIGH FREQUENCY
Guedel Oropharyngeal Airway
Berman Oropharyngeal Airway
Traditional Guedel Oropharyngeal Airway
Williams Oropharyngeal Airway
PVC Guedel Oropharyngeal Airway
E-Z Airway Laryngeal Mask
Air-Q3
Vent Mask II
Breath Tech Mask
Soft-Aire Mask
Vent Mask
Westmed Anesthesia Masks
MASK, GAS, ANESTHETIC
Circuit, breathing (w/ connector, adapter, y piece)
Circuit, Breathing (W connector, adaptor, Y piece)
CATHETER AND TIP, SUCTION
Water Solutions Saline And Sterile
Salter Humidifier
Adhesive Tape and Bandage
Oxygen Mask
MAXCAP Neo
MAXCAP Ped
Ventlab Nasal CPAP Interface
HUMIDIFIER, RESPIRATORY GAS
BreathTech HME
Medline HME
Ventlab HME
CONDENSER, HEAT AND MOISTURE
Tourniquet
Vein Stripper
Nebulizer
Salter Labs Nebulizer Exhalation Filter, 8980 Series
STAT-Check Resuscitator
HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
Circuits Heated Wire
Cyberwand Lithotripter with Sterile Probes
MONITOR, AIRWAY PRESSURE
Verify II
Protective Shield
Tracheostomy Tube
Aerial MDI Spacer
BreatheRite MDI Spacer
BlockAid Pulmonary Function Filter
Respiratory humidifier for emergency use
TUBE, ASPIRATING, FLEXIBLE, CONNECTING
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
NO MES
Ethox TUM-E-VAC Gastric Lavage Tubes
Humidifier, bubble, w/3PSI pop-off - 50/cs
CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Salter Labs 8900 Series Small Volume Jet Nebulizer
Salter Labs Bubble Humidifier
System, rebreathing, radionuclide
Reservoir Bag
Salter Labs NebuTech HDN Reusable Nebulizer
AirLife GSL
Tracheal suction set
Dressing, wound, drug
TUBING, NONINVASIVE
Airlife Infant Skin Temp Probe
Conserver, oxygen
Cannulas O2
CALCULATOR, PULMONARY FUNCTION DATA
1200 Infusion System
TIS-1200 Thermacor
DRAIN, TEE (WATER TRAP)
Infu-Surg Pressure Infusion Bag
Surgi-Press
Ventlab Pressure Infusion Bag
Clarity Infu-Surg Pressure Infusion Bag
Integrity Pressure Infusion Bag
Zefon InfuseIT Pressure Infusion Bag
InfuseOne Pressure Infusion Bag
Vital Signs Pressure Infuser
Westmed Breathing Circuits
Nox Medical Filter
Combiguard
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
MAXCAP
FLOCAP
Ventlab Pressure Tubing and Accessories
Oxygen Tubing
Cuff Sentry
Attachment, breathing, positive end expiratory pressure
Breathing Tube Support
Tube Tree
TRAY, SURGICAL
Thermal Angel
MASK, OXYGEN, LOW CONCENTRATION, VENTURI
Finger Pulse Oximeter
Pulse Oximeter
Ventilator, emergency, manual
Ventlab 6000 Series Humidifier
HMEF 500, 557070700, 557070500
PERCUSSOR
Nebulizers Large Volume Prefilled And Dry
ETCO2 Cannula
End Tidal CO2 Cannula
Medline Supersoft Adult Co2 Cannula
Lavage Tube
Ambu Hyperinflation System
SUPPORT, PATIENT POSITION
HEATER, BREATHING SYSTEM W/WO CONTROLLER
FLEXTUBES
Westmed GSL (Salter)
BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM (UNCALIBRATED)
Absorbent Medical Fiber
Cannulas Etco2
FRB-30
Ventlab PEEP Valve
VixOne
GreenLine®/D LED Conventional Laryngoscope Handle
GreenLine® Disposable Fiber Optic Laryngoscope Handle
GreenLine® Fiber Optic Laryngoscope Handle
GreenLine®/D Fiber Optic Laryngoscope Handle
GreenLine® Disposable Fiber Optic Laryngoscope Blade
Conventional Laryngoscope Blade
GreenLine®/D Fiber Optic Laryngoscope Blade
Conventional Disposable Laryngoscope Handle
Conventional Laryngoscope Handle
GreenLine® Fiber Optic Laryngoscope Blade
Fiber Optic Laryngoscope Blade
Conventional Disposable Laryngoscope Blade
SunOne System Laryngoscope Handle
SunOne System Laryngoscope Blade
Fiber Optic Laryngoscope Handle
GreenLine®/D LED Disposable Laryngoscope Handle
GreenLine®/D LED Laryngoscope Blade
Blade, Laryn, Vs, Plastic, Mil 2 & 3
Blade, Laryn, Vs, Plastic, Mac 2
SunSlip Stylette with Sheath
Ported ET Tube Introducer
SunGlide Stylette
ET Tube Introducer
Aluminum Disposable Stylette
Fiber Optic Stylette
Stainless Steel Stylette
Lighted Stylette
Solid Copper Stylette
Malleable Introducer
Hollow Copper Stylette
Aluminum Stylette
PVC Stylette
Coated Stylette
Airway suction kit
MiniHEART Nebulizer
AMBU Pedi CO2 Easy
Co2 Easy Ped
Sterile Water for Inhalation
Tube, tracheal
Ballard Metered Dose Inhaler (MDI) Adapter
CATHETERS, SUCTION, TRACHEOBRONCHIAL
Ballard Single Dose Vials, 0.9% Sodium Chloride Solution
Tube tracheostomy and tube cuff
Block
Bite
Filter, bacterial, breathing-circuit
Cardiopulmonary resuscitation aid kit
IV Catheter Securement
SunStim Plus
SunStim
Emergency response safety kit
Patient Circuits And Accessories Non-Heated
Stethoscope Head
Tubing/tubing with filter, insufflation, laparoscopic
Ventilator, non-continuous
Masks Non-Invasive Full Face And Nasal
Face Mask Neonate and Infant Disposable
Ventilator, emergency, manual (resuscitator)
STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL
Dental Protector
Flow Meter
Peak Flow Meter
Manual Resuscitator /w PEEP Valve
Genesis Low Temperature Reusable Rigid Container System
Wound Flash, Sterile Water & Normal Saline
O2Boot
O2Sacral
HMEF Mini/s
WaterPAP
Airlife Nebulizer
Patient personal hygiene kit
Valve, non-rebreathing
Westmed GSL
InspiRx
500 Series Nebulizer
TOOTHBRUSH, MANUAL
Ventlab Oxygen Mask
ETHOX GASTRIC LAVAGE KIT
Surgical Instrument Tray
Genesis Reusable Rigid Container System
Latex Free PVC Nasopharyngeal Airway
"Blue" Latex Robertazzi Nasopharyngeal Airway
Latex Free Adjustable Flange Nasopharyngeal Airway
Latex Free Robertazzi Nasopharyngeal Airway
Resuscitation Bags Flow-Inflating
Anesthesia breathing circuit kit (adult & pediatric)
Circuits Anesthesia
O2 Delivery Adapters And Connectors
Humidifiers Heated
Oxygen Cannula
Oxygen Masks
Mask Face Tent Disp
CANNULA, NASAL, OXYGEN
Mask Air Entrain Adult W/u-connect-it
Mouthpiece Universal Poly Disp
Mask Aerosol Hi-concent Disp Under Chin
Etco2 Cannula 7' U/connect-it Adult,male
Cannula Crvd N-flr Tip W/o Tb Disp
Adapter Trach T
Mixer, breathing gases, anesthesia inhalation
Thermometer, electronic, clinical
NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
Oxygen administration kit
Tongue Seizing Forceps
ENT Forceps
Magill Closed Tip Forceps
Magill Open Tip Forceps
ACCESSORY, SURGICAL APPAREL
BAG, URINE COLLECTING, URETEROSTOMY
Uni-Heart
Ventilator Set
STAT-Check II CO2 Indicator
Skin prep tray
Forceps
SPIROMETER, THERAPEUTIC
APPLICATOR, VAGINAL
CONTAINER, EMBEDDING
AirLife Bubble Humidifier
CONNECTOR, AIRWAY
CATHETER, IRRIGATION
HMEF 750, M1038639, M1010538, M1005260, M1004132
Surgi-Kit
BreathTech Hyperinflation System
Ventlab Hyperinflation System
Superno2va Nasal Interface
SunMed SafeT T-piece Resuscitator
THERMOMETER, CLINICAL COLOR CHANGE
Manual Pulmonary Resuscitator
STRAP, HEAD, GAS MASK
Urine Collector and Accessories for Indwelling Catheter
VARIABLE NEBULIZER HEATER
Humidifier nebulizer kit
Post-Op Socks
Surgical Clamp
CATHETER, RETENTION TYPE, BALLOON
Foley Catheter
PFT Filters
Ventlab BV Filter
Medline BV Filter
BreathTech BV Filter
Owens&Minor Breathing Circuit with Ventlab B/V Filter
MedLine HME Filter
Bronchoscope
AMBU CO2 Easy
CO2 Easy
Endotracheal Tube
BL
Stethoscope
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
CATHETER, NASAL, OXYGEN
Nose Clip
Aspirator
HMEF 1000, M1038637, M1010534, 8570230, 8570203, 557085500, 557071600, 557071500, 557050200 (EOL), 557019500
Tubes, gastrointestinal (and accessories)
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
Non-bronchoscopic bronchoalveolar lavage catheter
AirFlow Resuscitator
VCare Resuscitator
MOUTHPIECE, BREATHING
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
IGuard
Eye Protector
Vital Signs cardiac output Probe
HEART Nebulizer
Critical care ventilator
PressureChek
Adapters And Connectors (Ventilation Accessories)
DEVICE, FIXATION, TRACHEAL TUBE
Ophthalmoscope
Combi-Port IV Bag Spike
M1003346 Uni-Filter Junior, M1003345 Uni-Filter Mini, 557022500 Uni-Filter/S, 557021200 U-Filters
Filters, M1010541 Angled Uni-Filters/S
8570127 (EOL) Unifilter S (Bulk), 557051200 (EOL) Y-filter Plus Edith 1000
Bio-Back
Endobronchial Tube
Detectable Gauze
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Reprocess Single-Use Device
Manufacture Medical Device for Another Party (Contract Manufacturer)