Identity
- Trade Name
- CENTRIMAG® BACK-UP CONSOLE WITH BATTERIES FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump backup drive unit FDA UDI
- Device Name
- BACK-UP CONSOLE WITH BATTERIES FDA UDI
- Model / Reference
- 201-90200 FDA UDI
- Description
- BACK-UP CONSOLE WITH BATTERIES FDA UDI
Identifiers
- Catalog Number
- 201-90200 FDA UDI
- Primary DI / UDI-DI
- 07640135140870 FDA UDI
- FDA Product Code
- DWA FDA UDI
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump backup drive unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4380 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
No
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
No
FDA UDI
Category: Cardiopulmonary bypass system centrifugal pump backup drive unit
Centrimag® Back-Up Console With Batteries by Thoratec Switzerland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system centrifugal pump backup drive unit.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thoratec Switzerland GmbH
Sources (1)
- FDA UDI 3531b067-3bb4-4248-aced-832da0d13200 35 fields · synced May 31, 2026