Resuscitator Adaptor 37001
by Accutron
Resuscitator Adaptor 37001 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 00813830022742), 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 | Number00813830022742 | Date26 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK910040 | Date28 May 1991 | StatusActive |
Official records
- AccessGUDID record 00813830022742
- FDA 510(k) database K910040
Across registries
- FDA 510(k) K910040 decided 28 May 1991 Active
- FDA GUDID UDI-DI 00813830022742 listed 26 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K910040
- Listed FDA GUDID 00813830022742
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Resuscitator Adaptor
- Generic name
- Pulmonary resuscitator, manual, reusable
- Model / Ref / Catalog
- 37001
- Primary DI / UDI-DI
- 00813830022742
- 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
Similar devices
Other devices filed under FDA product code BTM (Ventilator, Emergency, Manual (Resuscitator)).
- FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR by Intertech/Ohio
- BAG Manual Resuscitator and Accessories by Laerdal Medical AS
- RESUSO MASK by Rml Ent., Inc.
- Disposable Manual Resuscitator by XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
- PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER by Puritan Bennett Corp.
- Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 by Cheen Houng Ent. Co., Ltd.
- PULMANEX TM (MODIFICATION) by Life Design Systems, Inc.
- RESUSCITATION MASK by Cederroth, Inc. USA
- RESUSCITATOR, PULMONARY, MANUAL by Life Design Systems, Inc.
- OHMEDA INFANT RESUSCITATION SYSTEM by Ohmeda Medical