Hand-held Resuscitator Ambu type 38012
by Accutron
Hand-held Resuscitator Ambu type 38012 is a Class II device made by Accutron, cleared under FDA 510(k) K910040 on 28 May 1991 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00813830022896), 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 | Number00813830022896 | Date26 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK910040 | Date28 May 1991 | StatusActive |
Official records
- AccessGUDID record 00813830022896
- FDA 510(k) database K910040
Across registries
- FDA 510(k) K910040 decided 28 May 1991 Active
- FDA GUDID UDI-DI 00813830022896 listed 26 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K910040
- Listed FDA GUDID 00813830022896
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hand-held Resuscitator Ambu type
- Generic name
- Pulmonary resuscitator, manual, reusable
- Model / Ref / Catalog
- 38012
- Primary DI / UDI-DI
- 00813830022896
- 510(k) Number
- FDA product code
- BTM
- GMDN term
- Pulmonary resuscitator, manual, reusable
- Device class
- Class II
- Regulation number
- 868.5915
- GUDID distribution status
- In Commercial Distribution
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- INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR by International Respiratory Systems, Inc.
- DRESSER ARGUS P/N 1818 by Dresser Argus, Inc.