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MPS 3 Drug Pump Cover

FDA UDI

Class II (US FDA UDI)

by Quest Medical Inc

Identity

Trade Name
MPS 3 Drug Pump Cover FDA UDI
Generic Name
Cardiopulmonary bypass system heat exchanger, reusable FDA UDI
Model / Reference
5303031 FDA UDI

Identifiers

Primary DI / UDI-DI
20634624530397 FDA UDI
510(k) Number
K200438 FDA UDI
K201984 FDA UDI
FDA Product Code
DTR FDA UDI
GMDN Term
Cardiopulmonary bypass system heat exchanger, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4240 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary bypass system heat exchanger, reusable

MPS 3 Drug Pump Cover 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

K200438 also covers:

K201984 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 8a1c3ac0-5bf5-4a31-a762-c8e856d5c398 33 fields · synced May 31, 2026