Bio-Med Devices, Inc. 2001F
Bio-Med Devices, Inc. 2001F is a Class II device made by Bio-Med Devices, Inc., cleared under FDA 510(k) K925982 on 7 Oct 1993 and listed in FDA GUDID since 2 Nov 2015 (UDI-DI 00813841020096), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00813841020096 | Date2 Nov 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK925982 | Date7 Oct 1993 | StatusActive |
Official records
- AccessGUDID record 00813841020096
- FDA 510(k) database K925982
Across registries
- FDA 510(k) K925982 decided 7 Oct 1993 Active
- FDA GUDID UDI-DI 00813841020096 listed 2 Nov 2015 Listed
Timeline
- Cleared FDA 510(k) K925982
- Listed FDA GUDID 00813841020096
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bio-Med Devices, Inc.
- Generic name
- Oxygen/air breathing gas mixer, hospital
- Model / Ref / Catalog
- 2001F
- Primary DI / UDI-DI
- 00813841020096
- 510(k) Number
- FDA product code
- MOD
- GMDN term
- Oxygen/air breathing gas mixer, hospital
- Device class
- Class II
- Regulation number
- 868.5895
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Oxygen/air breathing gas mixer, hospital.