Identity
- Trade Name
- Blender FDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, hospital FDA UDI
- Device Name
- BIRDTMLow Flow Air/O2Blender FDA UDI
- Model / Reference
- 10016A FDA UDI
- Description
- BIRDTMLow Flow Air/O2Blender FDA UDI
Identifiers
- Catalog Number
- 10016A FDA UDI
- Primary DI / UDI-DI
- 10190752174689 FDA UDI
- 510(k) Number
- K973646 FDA UDI
- FDA Product Code
- BZR FDA UDI
- GMDN Term
- Oxygen/air breathing gas mixer, hospital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oxygen/air breathing gas mixer, hospital
Blender by Vyaire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K973646 also covers:
- AirLife™ — VYAIRE MEDICAL, INC.
- BIRD™ — VYAIRE MEDICAL, INC.
- BIRD™ — VYAIRE MEDICAL, INC.
- BIRD™ — VYAIRE MEDICAL, INC.
- BIRD™ — VYAIRE MEDICAL, INC.
- BIRD™ — VYAIRE MEDICAL, INC.
- BIRD™ — VYAIRE MEDICAL, INC.
- Bird™ Sentry2 — VYAIRE MEDICAL, INC.
- Bird™ Sentry2 — VYAIRE MEDICAL, INC.
- Blender — VYAIRE MEDICAL, INC.
- Blender — VYAIRE MEDICAL, INC.
- Blender — VYAIRE MEDICAL, INC.
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
- Vyaire Medical, Inc.
Sources (1)
- FDA UDI b7c2da2b-f440-4aa6-a212-e12bf5d62988 37 fields · synced May 30, 2026