Identity
- Trade Name
- AB5000 FDA UDI
- Generic Name
- Implantable ventricular circulatory assist system FDA UDI
- Device Name
- Ventricular (Assist) Bypass FDA UDI
- Model / Reference
- AB Pump Set 12mm/42 Apical (Sil) FDA UDI
- Description
- Ventricular (Assist) Bypass FDA UDI
Identifiers
- Catalog Number
- 0055-1242-SV FDA UDI
- Primary DI / UDI-DI
- 00813502010404 FDA UDI
- PMA Number
- P900023 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- GMDN Term
- Implantable ventricular circulatory assist system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ab5000 by Abiomed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 III | Pending data |
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Manufacturer
- Manufacturer
- Abiomed, Inc.
Sources (1)
- FDA UDI bc1274d7-af45-4be7-a855-c37becb045fa 37 fields · synced Jun 8, 2026