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MPS Back Up System, front crank

FDA UDI

Class II (US FDA UDI)

by Quest Medical Inc

Identity

Trade Name
MPS Back Up System, front crank FDA UDI
Generic Name
Cardiopulmonary bypass system heat exchanger, reusable FDA UDI
Device Name
MPS Back Up System, front crank, blood only FDA UDI
Model / Reference
5001021 FDA UDI
Description
MPS Back Up System, front crank, blood only FDA UDI

Identifiers

Primary DI / UDI-DI
20634624510214 FDA UDI
510(k) Number
K002366 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Cardiopulmonary bypass system heat exchanger, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4210 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary bypass system heat exchanger, reusable

MPS Back Up System, front crank by Quest Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system heat exchanger, reusable.

Cleared under the same submission

K002366 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quest Medical Inc

Sources (1)

  • FDA UDI 80f095c2-b6a4-4fde-a55d-535e230a47d4 35 fields · synced Jun 1, 2026