Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Inhalation therapy sterile water FDA UDI
- Device Name
- Prefilled Humidifier, Sterile Water for Inhalation 350 mL FDA UDI
- Model / Reference
- 16-00350 FDA UDI
- Description
- Prefilled Humidifier, Sterile Water for Inhalation 350 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10612479257686 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Inhalation therapy sterile water
McKesson by Mckesson Medical-Surgical 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
- AMSure® Sterile Water for Inhalation, USP 1000mL — AMSINO INTERNATIONAL, INC. · Class II
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- HUDSON RCI — MEDLINE INDUSTRIES, INC. · 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 |
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Manufacturer
- Manufacturer
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI bcdc7b48-db54-42da-b052-0a3bfe8a94f1 33 fields · synced May 30, 2026