HeartWare® Battery 1650
HeartWare® Battery 1650 is a Class III device made by Heartware Inc., listed in FDA GUDID since 13 Aug 2014 (UDI-DI 00888707000079), not in commercial distribution (GUDID) as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00888707000079 | Date13 Aug 2014 | StatusListed |
Official records
- AccessGUDID record 00888707000079
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- HeartWare® Battery
- Generic name
- Implantable ventricular circulatory assist system
- Model / Ref / Catalog
- 1650
- Primary DI / UDI-DI
- 00888707000079
- FDA product code
- DSQ
- GMDN term
- Implantable ventricular circulatory assist system
- Device class
- Class III
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code DSQ (Ventricular (Assisst) Bypass).
- THORATEC® HEARTMATE II®, SEALED OUTFLOW BEND RELIEF COLLAR 107315 by Thoratec Corporation
- EXCOR® C85G-002 by Berlin Heart GmbH
- EXCOR® C22V-002 by Berlin Heart GmbH
- THORATEC® HEARTMATE® GOGEAR®, CONSOLIDATED BAG, RIGHT 104233 by Thoratec Corporation
- EXCOR Pediatric Ventricular Assist Device by Berlin Heart, Inc.
- Abiomed BVS 5000 Bi-Ventricular Support System by Abiomed Cardiovascular, Inc.
- NOVACOR LVAS by Worldheart, Inc.
- HeartWare Ventricular Assist System by MEDTRONIC, INC.
- CentriMag Circulatory Support System by Abbott
- Thoratec Ventricular Assist Device (VAD) System by Thoratec Laboratories Corp.