Identity
- Trade Name
- AirLife™ FDA UDI
- Generic Name
- Inhalation therapy saline solution, isotonic FDA UDI
- Device Name
- Prefill Nebulizer Kit FDA UDI
- Model / Reference
- CK4505 FDA UDI
- Description
- Prefill Nebulizer Kit FDA UDI
Identifiers
- Catalog Number
- CK4505 FDA UDI
- Primary DI / UDI-DI
- 10190752160194 FDA UDI
- FDA Product Code
- OGG FDA UDI
- GMDN Term
- Inhalation therapy saline solution, isotonic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Inhalation therapy saline solution, isotonic
AirLife™ by Airlife, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inhalation therapy saline solution, isotonic.
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Sodium Chloride Inhalation Solution, USP, 0.9%-3mL — LIFESTAR PHARMA LLC · Class II
- Sodium Chloride Inhalation Solution, USP 0.9% — Nephron Pharmaceuticals Corp. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Airlife, Inc.
Sources (1)
- FDA UDI 88668d14-ac18-40c0-b2a2-03541b4b6a56 36 fields · synced Jun 8, 2026