Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Non-rebreathing oxygen face mask FDA UDI
- Device Name
- Oxygen Mask ADULT, MEDIUM CONCENTRATION, 7’ (2.1 m) CRUSH RESISTANT TUBING MULTIDIRECTIONAL SWIVEL | SINGLE PATIENT USE FDA UDI
- Model / Reference
- 32633 FDA UDI
- Description
- Oxygen Mask ADULT, MEDIUM CONCENTRATION, 7’ (2.1 m) CRUSH RESISTANT TUBING MULTIDIRECTIONAL SWIVEL | SINGLE PATIENT USE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20612479208265 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
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: Non-rebreathing oxygen face mask
McKesson by Mckesson Medical-Surgical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-rebreathing oxygen face mask.
- POM EZ-Lite — Stryker Corp. · Class II
- BF — Allied Medical LLC · Class I
- Rescuer O-Mask — B.L.S. Systems Limited · Class I
- Resp-O2 Oxygen Mask High-Concentration, Elongated Adult — Dynarex Corp. · Class I
- BF — Allied Medical LLC · Class I
- Procedural Oxygen Mask — Stryker Corp. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Ventlab — Ventlab Corp. · 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
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI 7cbb1c2c-0418-431b-9ad7-6abd62a2fcdc 33 fields · synced May 30, 2026