FDA Registration Active 🇺🇸 United States

Masks Non-Invasive Full Face And Nasal

Reg #: 3030308442 · FEI: 3030308442 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
SUNMED GROUP HOLDINGS, LLC dba AirLife
Registration Number
3030308442
FEI Number
3030308442
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
15152 W. Camelback Rd.
City
Litchfield Park
State
AZ
ZIP
85340
Country
US

Regulatory Submissions

510(k) Number
K102120

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, Continuous, Facility Use CBK

Proprietary Names

Masks Non-Invasive Full Face And Nasal

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility