Identity
- Trade Name
- THORATEC® HEARTMATE®, SYSTEM MONITOR FDA UDI
- Generic Name
- Image display unit, colour FDA UDI
- Device Name
- SYSTEM MONITOR FDA UDI
- Model / Reference
- 1286A-US FDA UDI
- Description
- SYSTEM MONITOR FDA UDI
Identifiers
- Catalog Number
- 1286A-US FDA UDI
- Primary DI / UDI-DI
- 00813024010852 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- GMDN Term
- Image display unit, colour FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Image display unit, colour
Thoratec® Heartmate®, System Monitor by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 064b672a-1c01-471f-91b8-b0f82a58aa07 36 fields · synced Jun 8, 2026