Bio-Pump®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: BIO-PUMP® FDA UDI
Generic Name: Cardiopulmonary bypass system centrifugal pump FDA UDI
Device Name: PUMP 95171 BIOPUMP BP50 STER 3L 4PK FDA UDI
Model / Reference: 95171 FDA UDI
Description: PUMP 95171 BIOPUMP BP50 STER 3L 4PK FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994406934 FDA UDI
510(k) Number: K852807 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiopulmonary bypass system centrifugal pump

Bio-Pump® 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
Capiox® iCP Centrifugal Pump — Terumo Cardiovascular Systems Corporation · Class II
Sarns™ Centrifugal Pump without X-Coating™ — Terumo Cardiovascular Systems Corporation · Class II
Sarns™ Centrifugal Pump with X-Coating™ — Terumo Cardiovascular Systems Corporation · Class II
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

K852807 also covers:

Bio-Pump™ — MEDTRONIC, INC.
Bio-Pump™ — MEDTRONIC, INC.

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 d7be8d9d-84ce-4192-bd8e-e91ad1fa5ea5 36 fields · synced May 30, 2026