Identity
- Trade Name
- Biflo Nasal Mask FDA UDI
- Generic Name
- Oxygen administration face tent FDA UDI
- Device Name
- Biflo Nasal Mask w/7' KROT FDA UDI
- Model / Reference
- 0101 FDA UDI
- Description
- Biflo Nasal Mask w/7' KROT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078004308 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Oxygen administration face tent 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
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
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: Oxygen administration face tent
Biflo Nasal Mask by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen administration face tent.
- BF — Allied Medical LLC · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- Resp-O2 Nasal Oxygen High Flow Cannula, Cushion Tip — Dynarex Corp. · Class I
- Resp-O2 Nasal Oxygen High Flow Cannula, Cushion Tip — Dynarex Corp. · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Nasal Mask, Pediatric — WESTMED, INC. · 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
- Westmed, Inc.
Sources (1)
- FDA UDI 8b4d71f3-a2bc-4822-84e0-a9512afac147 33 fields · synced Jun 1, 2026