Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030308442

FEI Number

3030308442

Entity Name

SUNMED GROUP HOLDINGS, LLC dba AirLife

City/State/Country

Litchfield Park, AZ, US

Establishment Address

15152 W. Camelback Rd., Litchfield Park, AZ 85340, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

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

Expiration Date (Year)

2026

510(k) Number

K082092

PMA Number

N/A

All Registered Proprietary Names

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Nebulizers Large Volume Prefilled And Dry TUBE, ASPIRATING, FLEXIBLE, CONNECTING Face Mask Neonate and Infant Disposable Ventilator, emergency, manual (resuscitator)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-04-22
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2024-04-22
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

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
8030647	Westmed de Mexico, S.A de C.V	MAGDALENA Sonora, MX
3006606984	Westmed de Mexico, S.A de C.V	NOGALES Sonora, MX
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US
3010838917	AirLife Finland Oy	Helsinki Uusimaa, FI

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

Similar Registrations

Registration Number	Establishment Name	Location
3010063021	TNI MEDICAL AG	Wurzburg Bavaria, DE
2085602	FISHER & PAYKEL HEALTHCARE, INC.	IRVINE, CA, US
3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH
3011137372	Teleflex Medical LLC	Morrisville, NC, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030308442. Last updated year: 2026. Please use registration number 3030308442 when referencing this establishment in official correspondence.