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Terumo® Advanced Perfusion System 1

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name
Terumo® Advanced Perfusion System 1 FDA UDI
Generic Name
Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
Device Name
The centrifugal control unit provides the local display and control mechanism for the centrifugal motor and disposable pump and serves as the interface between the centrifugal motor and the rest of the system. The local display indicates the motor speed, flow rate, and safety, status and error messages. The pump can be controlled from either the CCM or from the control knob on the control unit. FDA UDI
Model / Reference
816572 FDA UDI
Description
The centrifugal control unit provides the local display and control mechanism for the centrifugal motor and disposable pump and serves as the interface between the centrifugal motor and the rest of the system. The local display indicates the motor speed, flow rate, and safety, status and error messages. The pump can be controlled from either the CCM or from the control knob on the control unit. FDA UDI

Identifiers

Catalog Number
816572 FDA UDI
Primary DI / UDI-DI
00886799001387 FDA UDI
FDA Product Code
DTQ FDA UDI
GMDN Term
Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4220 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

Terumo® Advanced Perfusion System 1 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.

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 2af4b7dd-5c24-4b09-bf3c-3cdf6f9006f8 34 fields · synced Jun 9, 2026