Identity
- Trade Name
- BF FDA UDI
- Generic Name
- Aerosol face mask, rebreathing, reusable FDA UDI
- Device Name
- ADULT,AEROSOL MASK,78"SF FDA UDI
- Model / Reference
- HCS4495 FDA UDI
- Description
- ADULT,AEROSOL MASK,78"SF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00026072023860 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Aerosol face mask, rebreathing, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Aerosol face mask, rebreathing, reusable
Bf by Allied Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aerosol face mask, rebreathing, reusable.
- EM — Allied Medical LLC · Class I
- BF — Allied Medical LLC · Class I
- BF — Allied Medical LLC · Class I
- BF — Allied Medical LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Allied Medical LLC
Sources (1)
- FDA UDI 5960e724-57e3-49af-9808-3a5049fa3db4 33 fields · synced Jun 8, 2026