Data / Medical devices / United States / SUNMED GROUP HOLDINGS, LLC dba AirLife
SUNMED GROUP HOLDINGS, LLC dba AirLife: FDA-registered device maker in Litchfield Park, AZ, United States, 4 510(k) clearances
SUNMED GROUP HOLDINGS, LLC dba AirLife is registered with the FDA (registration 3030308442) in Litchfield Park, AZ, United States. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 22, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3030308442
- Address
- 15152 W. Camelback Rd., Litchfield Park, AZ, United States, 85340
- Owner or operator
- SunMed Group Holdings, LLC dba AirLife (10044795)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- July 18, 2023
- Registered through
- 2027
- Brand names listed
- CABLE, TRANSDUCER AND ELECTRODE, PATIENT, CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION, Face Mask Neonate and Infant Disposable, HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE), Humidifier nebulizer kit, Nebulizers Large Volume Prefilled And Dry, TUBE, ASPIRATING, FLEXIBLE, CONNECTING, Ventilator, emergency, manual (resuscitator)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Calculator, Predicted Values, Pulmonary Function | BTY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Humidifier Nebulizer Kit | OGG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 22, 2017 | K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | DSA | Substantially Equivalent | Carefusion 303, Inc. | accessdata.fda.gov |
| October 15, 2008 | K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | BTM | Substantially Equivalent | Galemed Corp. | accessdata.fda.gov |
| November 22, 1994 | K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS | BTY | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| August 6, 1985 | K853146 | RESPIR THER HUMID CONTAIN STERILE WATER FOR USP | BTT | Substantially Equivalent | Automatic Liquid Packaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Aspirating, Flexible, Connecting
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Ventilator, Emergency, Manual (Resuscitator)
- All makers of Attachment, Breathing, Positive End Expiratory Pressure
- All makers of Calculator, Predicted Values, Pulmonary Function
Updated June 22, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.