Identity
- Trade Name
- ROTAFLOW FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump FDA UDI
- Device Name
- BEQ-RF-32-USA#RotaFlow Centrifugal Pump with BIOLINE Coating FDA UDI
- Model / Reference
- Centrifugal Pump, BIOLINE FDA UDI
- Description
- BEQ-RF-32-USA#RotaFlow Centrifugal Pump with BIOLINE Coating FDA UDI
Identifiers
- Catalog Number
- 70104.7554 FDA UDI
- Primary DI / UDI-DI
- 04037691530864 FDA UDI
- 510(k) Number
- K080470 FDA UDI
- FDA Product Code
- KFM FDA UDI
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary bypass system centrifugal pump
Rotaflow by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiopulmonary bypass system centrifugal pump.
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- Bio-Pump™ — MEDTRONIC, INC. · Class II
- Affinity™ CP — MEDTRONIC, INC. · Class II
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 |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
Sources (1)
- FDA UDI a12f997c-5851-41e2-b2c4-c5ba2c49c468 37 fields · synced May 30, 2026