Identity
- Trade Name
- BF FDA UDI
- Generic Name
- Non-rebreathing oxygen face mask FDA UDI
- Device Name
- MASK,ADULT,HIGH CONCENTRATION, FDA UDI
- Model / Reference
- 64007 FDA UDI
- Description
- MASK,ADULT,HIGH CONCENTRATION, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00026072023013 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Non-rebreathing oxygen face mask 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: Non-rebreathing oxygen face mask
Bf by Allied Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-rebreathing oxygen face mask.
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- Resp-O2 Oxygen Mask High-Concentration, Elongated Adult — Dynarex Corp. · Class I
- Procedural Oxygen Mask — Stryker Corp. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Ventlab — Ventlab Corp. · Class I
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · 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 2dd5aba6-54d8-4383-b90e-6dc7abe93ca8 33 fields · synced May 30, 2026