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Sarns™ Centrifugal System

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name
Sarns™ Centrifugal System FDA UDI
Generic Name
Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
Device Name
Centrifugal Pump Back-Up Battery FDA UDI
Model / Reference
9490 FDA UDI
Description
Centrifugal Pump Back-Up Battery FDA UDI

Identifiers

Catalog Number
9490 FDA UDI
Primary DI / UDI-DI
00886799000120 FDA UDI
510(k) Number
K902198 FDA UDI
FDA Product Code
KFM FDA UDI
GMDN Term
Cardiopulmonary bypass system centrifugal pump drive unit 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

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 centrifugal pump drive unit

Sarns™ Centrifugal System by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system centrifugal pump drive unit.

Cleared under the same submission

K902198 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Terumo Cardiovascular Systems Corporation

Sources (1)

  • FDA UDI b45f05dd-b680-48a9-9c3c-36750e27a34c 35 fields · synced Jun 9, 2026