Identity
- Trade Name
- AFFINITY® NT FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
- Device Name
- RESERVOIR 61399409462 AFFINITY 540 4PK FDA UDI
- Model / Reference
- 61399409462 FDA UDI
- Description
- RESERVOIR 61399409462 AFFINITY 540 4PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994375667 FDA UDI
- 510(k) Number
- K936003 FDA UDI
- FDA Product Code
- DTN FDA UDI
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4400 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
No
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 drive unit
Affinity® Nt 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 drive unit.
- Anivia SG1000 Pump Console — Asia Pacific Medical Technology Development Company Limited · Class II
- Anivia SG1000 Pump Console — Apmtd, Inc. · Class II
- Sarns™ Centrifugal System — Terumo Cardiovascular Systems Corporation · Class II
- Anivia SG1000 Pump Console — Apmtd, Inc. · Class II
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd. · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- Sarns™ Centrifugal System — Terumo Cardiovascular Systems Corporation · Class II
- METAL LOCKING FEATURE FOR CENTRIMAG MOTOR — Thoratec Switzerland GmbH · Class II
Cleared under the same submission
K936003 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 901abc71-8647-43dc-a8c6-bec0280cd00b 36 fields · synced Jun 6, 2026