Identity
- Trade Name
- AirLife FDA UDI
- Generic Name
- Inhalation therapy sterile water FDA UDI
- Device Name
- WATER STERILE IN HANGING BOTTLE 2000mL FDA UDI
- Model / Reference
- CHB0020 FDA UDI
- Description
- WATER STERILE IN HANGING BOTTLE 2000mL FDA UDI
Identifiers
- Catalog Number
- CHB0020 FDA UDI
- Primary DI / UDI-DI
- 10889483598535 FDA UDI
- 510(k) Number
- K830895 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Inhalation therapy sterile water FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inhalation therapy sterile water
AirLife by Airlife, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 350mL — AMSINO INTERNATIONAL, INC. · Class II
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- HUDSON RCI — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K830895 also covers:
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 |
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Manufacturer
- Manufacturer
- Airlife, Inc.
Sources (1)
- FDA UDI 2e73c239-30fc-41f8-877b-e10f61372344 36 fields · synced Jun 8, 2026