Identity
- Trade Name
- Bio-Med Devices, Inc. FDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, hospital FDA UDI
- Device Name
- Air / Oxygen Blender low flow MR-conditional FDA UDI
- Model / Reference
- 2003MB FDA UDI
- Description
- Air / Oxygen Blender low flow MR-conditional FDA UDI
Identifiers
- Catalog Number
- 2003MB FDA UDI
- Primary DI / UDI-DI
- 00813841021222 FDA UDI
- 510(k) Number
- K925982 FDA UDI
- FDA Product Code
- MOD FDA UDI
- GMDN Term
- Oxygen/air breathing gas mixer, hospital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Oxygen/air breathing gas mixer, hospital
Bio-Med Devices, Inc. by Bio-Med Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K925982 also covers:
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc.
- Bio-Med Devices, Inc. — Bio-Med Devices, 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
- Bio-Med Devices, Inc.
Sources (1)
- FDA UDI 60b6e7cf-2cf0-46a9-a082-6d904a2f5138 36 fields · synced Jun 9, 2026