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Thoratec® Heartmate Ii®, Pump And Controller Only Kit
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- THORATEC® HEARTMATE II®, PUMP AND CONTROLLER ONLY KIT FDA UDI
- Generic Name
- Implantable ventricular circulatory assist system FDA UDI
- Model / Reference
- 105903 FDA UDI
Identifiers
- Catalog Number
- 105903 FDA UDI
- Primary DI / UDI-DI
- 00813024011217 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Implantable ventricular circulatory assist system
Thoratec® Heartmate Ii®, Pump And Controller Only Kit by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable ventricular circulatory assist system.
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- HVAD® Pump Surgical Tools — Heartware Inc. · Class III
- Explant Kit — Heartware Inc. · Class III
- HeartWare® Monitor — Heartware Inc. · Class III
- HVAD® Controller — Heartware Inc. · Class III
- HeartWare® Battery — Heartware Inc. · Class III
- Data Cable — Heartware Inc. · Class III
- HVAD® Pump Surgical Tools – Extended Length — Heartware Inc. · Class III
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
- Thoratec Corp
Sources (1)
- FDA UDI 49b02bc0-971a-4070-b0e7-b1236d15445b 35 fields · synced May 30, 2026