SunMed Group Holdings, LLC

FDA Device Registration & Listing · Grand Rapids, MI, US · Registration 1314417

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1314417
FEI Number
1314417
Entity Name
SunMed Group Holdings, LLC
City/State/Country
Grand Rapids, MI, US
Establishment Address
2710 Northridge Dr NW Ste A, Grand Rapids, MI 49544, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
SunMed Group Holdings, LLC dba AirLife (Owner Number: 10044795)
Owner / Operator Contact Address
2710 Northridge Drive NW, Suite A, Grand Rapids, MI 49544, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K870332
PMA Number
N/A

All Registered 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 Nebulizer 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 Water Solutions Saline And Sterile 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 Nebulizer AirLife GSL Tracheal suction set Circuits Heated Wire 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 Nebulizer 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 Attachment, breathing, positive end expiratory pressure Nebulizers Large Volume Prefilled And Dry ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 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 HUMIDIFIER, RESPIRATORY GAS Ventilator, emergency, manual Nebulizer Westmed GSL (Salter) BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM (UNCALIBRATED) NO MES Absorbent Medical Fiber ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Cannulas Etco2 FRB-30 Ventlab PEEP Valve Nebulizer 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 Nebulizer Cardiopulmonary resuscitation aid kit Ventilator, emergency, manual IV Catheter Securement Ventilator, emergency, manual SunStim Plus SunStim Emergency response safety kit Filter, bacterial, breathing-circuit Patient Circuits And Accessories Non-Heated Stethoscope Head Tubing/tubing with filter, insufflation, laparoscopic Nebulizer Ventilator, non-continuous Masks Non-Invasive Full Face And Nasal Nebulizers Large Volume Prefilled And Dry Water Solutions Saline And Sterile HUMIDIFIER, RESPIRATORY GAS Water Solutions Saline And Sterile Face Mask Neonate and Infant Disposable Ventilator, emergency, manual (resuscitator) STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL Dental Protector Lavage Tube CALCULATOR, PULMONARY FUNCTION DATA Tube, tracheal Flow Meter Peak Flow Meter Manual Resuscitator /w PEEP Valve Genesis Low Temperature Reusable Rigid Container System HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER Wound Flash, Sterile Water & Normal Saline O2Boot O2Sacral SunStim SunStim Plus HMEF Mini/s WaterPAP MASK, GAS, ANESTHETIC ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Airlife Nebulizer Ventilator, emergency, manual HUMIDIFIER, RESPIRATORY GAS Patient personal hygiene kit Valve, non-rebreathing Westmed GSL InspiRx 500 Series Nebulizer Nebulizer TOOTHBRUSH, MANUAL Ventlab Oxygen Mask Oxygen Mask NO MES 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 Circuits Heated Wire Resuscitation Bags Flow-Inflating Anesthesia breathing circuit kit (adult & pediatric) Circuits Anesthesia O2 Delivery Adapters And Connectors Nebulizers Large Volume Prefilled And Dry Westmed Breathing Circuits Humidifiers Heated Oxygen Cannula Oxygen Masks Oxygen Tubing 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 Resuscitation Bags Flow-Inflating Thermometer, electronic, clinical NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) Ventilator, non-continuous 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 Nebulizer Skin prep tray Forceps SPIROMETER, THERAPEUTIC APPLICATOR, VAGINAL CONTAINER, EMBEDDING AirLife Bubble Humidifier Nebulizer CONNECTOR, AIRWAY CATHETER, IRRIGATION HMEF 750, M1038639, M1010538, M1005260, M1004132 Surgi-Kit BreathTech Hyperinflation System Ventlab Hyperinflation System MASK, GAS, ANESTHETIC Superno2va Nasal Interface Attachment, breathing, positive end expiratory pressure SunMed SafeT T-piece Resuscitator THERMOMETER, CLINICAL COLOR CHANGE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LSZ Ventilator, High Frequency Unknown Class 3 N/A 2023-07-18
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2018-04-05
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2018-01-17
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-08-09
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-08-09
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2018-01-17
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2023-07-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2026-06-10
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-08-09
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2018-01-18
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 2018-04-05
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2020-04-10
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2026-01-22
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2018-01-30
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2023-07-18
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2018-01-17
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2018-01-18
GAJ Stripper, Vein, Disposable General, Plastic Surgery Class 1 878.4800 2018-01-17
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2026-01-22
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2018-01-30
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2024-08-09
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2023-07-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-08-09
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2013-08-07
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2023-07-18
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2025-12-19
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2018-01-30
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2018-01-18
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2023-07-18
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2020-01-02
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2018-01-30
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2024-08-09
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2024-08-09
QOP Respiratory Humidifier For Emergency Use Unknown Class N N/A 2023-07-20
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2024-04-22
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2023-07-18
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-08-01
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2026-01-23
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2026-01-23
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2024-04-22
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2026-01-22
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2026-05-06
IYT System, Rebreathing, Radionuclide Radiology Class 2 892.1390 2023-07-18
BTC Bag, Reservoir Anesthesiology Class 1 868.5320 2018-04-09
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2026-01-22
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2025-12-11
OFS Tracheal Suction Set Anesthesiology Class 1 868.6810 2023-07-20
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2024-07-03
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-08-08
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2023-07-18
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2024-07-22
NFB Conserver, Oxygen Anesthesiology Class 2 868.5905 2023-07-18
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2024-04-22
FRN Pump, Infusion General Hospital Class 2 880.5725 2013-08-07
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2013-08-07
BYH Drain, Tee (Water Trap) Anesthesiology Class 1 868.5995 2018-01-30
KZD Infusor, Pressure, For I.V. Bags General Hospital Class 1 880.5420 2013-08-01
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2024-01-04
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2019-04-17
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2013-08-02
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2023-07-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2019-04-03
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2018-01-17
BSK Cuff, Tracheal Tube, Inflatable Anesthesiology Class 2 868.5750 2018-01-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2013-08-07
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2023-07-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
JAY Support, Breathing Tube Anesthesiology Class 1 868.5280 2018-04-09
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2023-07-18
BSB Warmer, Blood, Non-Electromagnetic Radiation Hematology Class 2 864.9205 2013-08-07
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2013-08-07
BYF Mask, Oxygen, Low Concentration, Venturi Anesthesiology Class 1 868.5600 2023-07-18
DQA Oximeter Cardiovascular Class 2 870.2700 2018-04-05
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2023-07-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2018-01-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-08-09
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2024-01-23
BYI Percussor, Powered-Electric Anesthesiology Class 2 868.5665 2024-11-01
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2023-07-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2023-07-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2018-01-18
KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Gastroenterology, Urology Class 2 876.5980 2013-08-02
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2025-12-12
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-08-09
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2023-07-18
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2023-07-18
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2024-08-09
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-09-04
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2023-07-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-02-11
CBC Bottle, Collection And Trap, Breathing System (Uncalibrated) General Hospital Class 2 880.6740 2018-01-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-08-01
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2018-01-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2023-07-18
KNH Laparoscopic Contraceptive Tubal Occlusion Device Obstetrics/Gynecology Class 3 884.5380 2017-03-24
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2018-01-30
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2018-01-30
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2018-04-05
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-08-09
OFO Airway Suction Kit Anesthesiology Class 1 868.6810 2023-07-20
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-09-26
NVP Holding Chambers, Direct Patient Interface Anesthesiology Class 2 868.5630 2018-01-18
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2024-08-09
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-08-09
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-11-19
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2026-01-09
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2023-07-18
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2023-07-18
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2023-07-18
JXL Block, Bite Neurology Class 2 882.5070 2013-08-02
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2023-07-18
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2024-08-09
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
OEV Cardiopulmonary Resuscitation Aid Kit Anesthesiology Class 2 868.5915 2023-07-20
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2023-07-18
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2018-01-18
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2023-07-18
BXN Stimulator, Nerve, Battery-Powered Anesthesiology Class 2 868.2775 2018-01-30
OKI Emergency Response Safety Kit General, Plastic Surgery Class 2 878.4040 2023-07-20
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2023-07-18
BZS Stethoscope Head Anesthesiology Class 1 868.1930 2018-04-05
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2023-07-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-08-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-07-18
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2024-07-03
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-07-03
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2023-07-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-07-03
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2024-04-22
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2024-04-22
KPD Strip, Temperature, Forehead, Liquid Crystal General Hospital Class 2 880.2200 2023-07-18
BRW Protector, Dental Anesthesiology Class 1 868.5820 2018-01-17
KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Gastroenterology, Urology Class 2 876.5980 2013-08-02
BTY Calculator, Predicted Values, Pulmonary Function Anesthesiology Class 2 868.1890 2024-04-22
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2024-04-22
JEH Plethysmograph, Volume Anesthesiology Class 2 868.1760 2024-04-22
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2023-07-18
CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated Anesthesiology Class 1 868.2340 2018-04-05
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2018-01-30
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2018-01-30
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-10-19
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2023-07-18
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-07-09
KPJ Chamber, Oxygen, Topical, Extremity General, Plastic Surgery Class 2 878.5650 2018-08-23
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2025-12-19
BXN Stimulator, Nerve, Battery-Powered Anesthesiology Class 2 868.2775 2018-01-30
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2024-02-28
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2025-12-11
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2023-07-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2023-07-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2025-12-11
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2023-07-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2023-07-18
NSB Patient Personal Hygiene Kit Dental Class 1 872.6855 2024-11-01
CBP Valve, Non-Rebreathing Anesthesiology Class 2 868.5870 2023-07-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2024-05-30
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2024-05-30
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2018-01-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
EFW Toothbrush, Manual Dental Class 1 872.6855 2024-11-01
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2018-01-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-08-01
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-01-17
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-10-19
BTQ Airway, Nasopharyngeal Anesthesiology Class 1 868.5100 2018-04-05
OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric) Anesthesiology Class 1 868.5240 2023-07-20
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2018-01-30
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2024-08-09
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2023-07-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-07-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-08-09
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2018-01-30
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-07-18
OGL Oxygen Administration Kit Anesthesiology Class 2 868.5655 2023-07-20
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2018-04-09
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2023-07-18
EXG Bag, Urine Collecting, Ureterostomy Gastroenterology, Urology Class 1 876.5900 2018-01-30
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2025-05-01
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2018-01-18
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2018-01-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
OJU Skin Prep Tray General, Plastic Surgery Class 1 878.4800 2023-07-20
HTD Forceps General, Plastic Surgery Class 1 878.4800 2018-04-05
BWF Spirometer, Therapeutic (Incentive) Anesthesiology Class 2 868.5690 2023-07-18
HGD Applicator, Vaginal Obstetrics/Gynecology Class 1 884.4520 2023-07-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2024-08-09
KER Container, Embedding Pathology Class 1 864.3010 2023-07-18
KFZ Humidifier, Non-Direct Patient Interface (Home-Use) Anesthesiology Class 1 868.5460 2025-11-19
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2023-07-18
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2018-04-05
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2023-07-18
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2024-01-23
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-08-02
NHK Resuscitator, Manual, Non Self-Inflating Anesthesiology Class 2 868.5905 2018-01-30
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2023-07-18
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2023-07-18
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 2024-08-09
CBP Valve, Non-Rebreathing Anesthesiology Class 2 868.5870 2024-08-09
BTL Ventilator, Emergency, Powered (Resuscitator) Anesthesiology Class 2 868.5925 2019-01-07
FQZ Thermometer, Clinical Color Change General Hospital Class 1 880.2900 2023-07-18
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2024-08-09

Official Correspondent

Rob Yamashita

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SunMed Group Holdings, LLC dba AirLife
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010362947 Shenzhen Vital Signs-KTL Medical Instrument Co Ltd Shenzhen Guangdong, CN
3030308442 SUNMED GROUP HOLDINGS, LLC dba AirLife Litchfield Park, AZ, US
8030647 Westmed de Mexico, S.A de C.V MAGDALENA Sonora, MX
3006606984 Westmed de Mexico, S.A de C.V NOGALES Sonora, MX
3010838917 AirLife Finland Oy Helsinki Uusimaa, FI

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07
K012633 Respironics, Inc. RESPIRONICS HEATED HUMIDIFIER 2002-02-28
K970478 Marquest Medical Products, Inc. SCT 3000 HEATED HUMIDIFIER 1997-07-16
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2014 King Systems Corp. 1
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0033-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04 VIASYS Med Systems 1
Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

Similar Registrations

Registration Number Establishment Name Location
3032745446 Cutler Campus North Salt Lake, UT, US
1220908 ZOLL MEDICAL CORPORATION CHELMSFORD, MA, US
3013421741 VYAIRE MEDICAL, INC. Mettawa, IL, US
2021710 ZOLL Palm Springs Palm Springs, CA, US
3037007211 ARETE MEDICAL DEVICES Mullica Hill, NJ, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1314417. Last updated year: 2026. Please use registration number 1314417 when referencing this establishment in official correspondence.
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