FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife™
DI: 10889483221891
·
Model: 0792
·
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
- 10889483221891
- Version / Model
- 0792
- Catalog Number
- 0792
- 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
- 5e9a06a3-9289-429b-a86c-9edb5449de27
Device Description
AirLife™ Composite Respiratory Kits, 1- High Flow Humidifier, 1- Salter-Style™ Soft Oxygen Cannula Adult High Flow 7' 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | Anesthesiology | 868.5460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60856 | Oxygen administration kit | A collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889483221891 | GS1 | ||||
| Previous | 00709078003011 | GS1 | ||||
| Package | 20889483221898 | GS1 | Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]