Identity
- Trade Name
- Affinity™ FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump FDA UDI
- Device Name
- PUMP AP40 AFFINITY CP CENTRIFUGAL NC FDA UDI
- Model / Reference
- AP40 FDA UDI
- Description
- PUMP AP40 AFFINITY CP CENTRIFUGAL NC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000134532 FDA UDI
- 510(k) Number
- K132712 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary bypass system centrifugal pump
Affinity™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system centrifugal pump.
- Quantum PureFlow Centrifugal Blood Pump CP22 — SPECTRUM MEDICAL LIMITED · Class II
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- CentriMag™ — Thoratec Switzerland GmbH · Class II
- VitalFlow Centrifugal Pump — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
- Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors — SPECTRUM MEDICAL LIMITED · Class II
- Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors — SPECTRUM MEDICAL LIMITED · Class II
Cleared under the same submission
K132712 also covers:
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
- Medtronic, Inc.
Sources (1)
- FDA UDI 597b92c6-52ea-4bc5-9b39-04f46fe92a7a 36 fields · synced May 30, 2026