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
Ventilator, High Frequency LSZ
Airway, Oropharyngeal, Anesthesiology CAE
Mask, Gas, Anesthetic BSJ
Nebulizer (Direct Patient Interface) CAF
Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
Catheter And Tip, Suction JOL
Tape And Bandage, Adhesive KGX
Mask, Oxygen, Non-Rebreathing KGB
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Ventilator, Non-Continuous (Respirator) BZD
Condenser, Heat And Moisture (Artificial Nose) BYD
Tourniquet, Nonpneumatic GAX
Stripper, Vein, Disposable GAJ
Ventilator, Emergency, Manual (Resuscitator) BTM
Connector, Airway (Extension) BZA
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
Lithotriptor, Electro-Hydraulic FFK
Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
Tube, Tracheal (W/Wo Connector) BTR
Shield, Protective, Personnel KPY
Applicator, Absorbent Tipped, Non-Sterile KXF
Tube, Tracheostomy (W/Wo Connector) BTO
Filter, Bacterial, Breathing-Circuit CAH
Respiratory Humidifier For Emergency Use QOP
Tube, Aspirating, Flexible, Connecting BYY
Tubes, Gastrointestinal (And Accessories) KNT
Ventilatory Effort Recorder MNR
Monitor, Breathing Frequency BZQ
Calculator, Predicted Values, Pulmonary Function BTY
Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
System, Rebreathing, Radionuclide IYT
Bag, Reservoir BTC
Tracheal Suction Set OFS
Dressing, Wound, Drug FRO
Tubing, Noninvasive GAZ
Warmer, Infant Radiant FMT
Conserver, Oxygen NFB
Calculator, Pulmonary Function Data BZC
Pump, Infusion FRN
Warmer, Thermal, Infusion Fluid LGZ
Drain, Tee (Water Trap) BYH
Infusor, Pressure, For I.V. Bags KZD
Syringe, Irrigating (Non Dental) KYZ
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Tubing, Pressure And Accessories BYX
Cuff, Tracheal Tube, Inflatable BSK
Orthopedic Stereotaxic Instrument OLO
Attachment, Breathing, Positive End Expiratory Pressure BYE
Support, Breathing Tube JAY
Tray, Surgical LRP
Warmer, Blood, Non-Electromagnetic Radiation BSB
Mask, Oxygen, Low Concentration, Venturi BYF
Oximeter DQA
Set, Administration, Intravascular FPA
Percussor, Powered-Electric BYI
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration KDH
Mixer, Breathing Gases, Anesthesia Inhalation BZR
Support, Patient Position CCX
Bottle, Collection And Trap, Breathing System (Uncalibrated) CBC
Fiber, Medical, Absorbent FRL
Laparoscopic Contraceptive Tubal Occlusion Device KNH
Laryngoscope, Rigid CCW
Stylet, Tracheal Tube BSR
Airway Suction Kit OFO
Holding Chambers, Direct Patient Interface NVP
Catheters, Suction, Tracheobronchial BSY
Tube Tracheostomy And Tube Cuff JOH
Block, Bite JXL
Cardiopulmonary Resuscitation Aid Kit OEV
Device, Intravascular Catheter Securement KMK
Stimulator, Nerve, Battery-Powered BXN
Emergency Response Safety Kit OKI
Stethoscope Head BZS
Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
Ventilator, Continuous, Facility Use CBK
Strip, Temperature, Forehead, Liquid Crystal KPD
Protector, Dental BRW
Plethysmograph, Volume JEH
Flowmeter, Tube, Thorpe, Back-Pressure Compensated CAX
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Chamber, Oxygen, Topical, Extremity KPJ
Patient Personal Hygiene Kit NSB
Valve, Non-Rebreathing CBP
Cannula, Nasal, Oxygen CAT
Toothbrush, Manual EFW
Mask, Oxygen BYG
Tray, Surgical, Instrument FSM
Airway, Nasopharyngeal BTQ
Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Continuous Measurement Thermometer FLL
Oxygen Administration Kit OGL
Forceps, Ent KAE
Accessory, Surgical Apparel LYU
Bag, Urine Collecting, Ureterostomy EXG
Set, Tubing And Support, Ventilator (W Harness) BZO
Skin Prep Tray OJU
Forceps HTD
Spirometer, Therapeutic (Incentive) BWF
Applicator, Vaginal HGD
Container, Embedding KER
Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
Catheter, Irrigation GBX
Resuscitator, Manual, Non Self-Inflating NHK
Ventilator, Emergency, Powered (Resuscitator) BTL
Thermometer, Clinical Color Change FQZ
Strap, Head, Gas Mask BTK
Collector, Urine, (And Accessories) For Indwelling Catheter KNX
Humidifier Nebulizer Kit OGG
Cover, Limb IPM
Tray, Surgical, Ent MMO
Clamp, Surgical, General & Plastic Surgery GDJ
Electrocardiograph DPS
Catheter, Retention Type, Balloon EZL
Bronchoscope (Flexible Or Rigid) EOQ
Stethoscope, Manual LDE
Catheter, Nasal, Oxygen BZB
Clip, Nose BXJ
Probe, Ent KAK
Non-Bronchoscopic Bronchoalveolar Lavage Catheter OYI
Mouthpiece, Breathing BYP
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Catheter, Oximeter, Fiber-Optic DQE
Critical Care Ventilator QOV
Device, Fixation, Tracheal Tube CBH
Ophthalmoscope, Battery-Powered HLJ
Set, I.V. Fluid Transfer LHI
Orthosis, Lumbar IQE
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
Gauze/Sponge, Internal, X-Ray Detectable GDY

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)