FDA UDI In Commercial Distribution 🇺🇸 United States

AirLife™

DI: 10889483221907 · Model: 0793 · SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

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Basic Information

Brand Name
AirLife™
Primary DI
10889483221907
Version / Model
0793
Catalog Number
0793
Company Name
SUNMED, LLC
Labeler DUNS
069009268
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-16
Public Version
1
Public Version Date
2025-12-24
Public Version Status
New
Public Device Record Key
cf5aab7b-a935-46b5-930c-f8a1dd1fac10

Device Description

AirLife™ Composite Respiratory Kits, 1- High Flow Humidifier, 1- Salter-Style™ Soft Oxygen Cannula Adult High Flow 14' Tubing

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KFZ Humidifier, Non-Direct Patient Interface (Home-Use)

GMDN Terms

Code Name
60856 Oxygen administration kit

Identifiers

Type ID
Primary 10889483221907
Previous 00709078003028
Package 20889483221904

Customer Contacts