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, roller type FDA UDI
Device Name: Roller pump hand cranks used to rotate the roller pump occlusion mechanism during an electrical power failure. These hand cranks can be used on either the large 6" or the small 4" roller pumps. FDA UDI
Model / Reference: 801016 FDA UDI
Description: Roller pump hand cranks used to rotate the roller pump occlusion mechanism during an electrical power failure. These hand cranks can be used on either the large 6" or the small 4" roller pumps. FDA UDI

Identifiers

Catalog Number: 801016 FDA UDI
Primary DI / UDI-DI: 00886799000526 FDA UDI
510(k) Number: K151349 FDA UDI
FDA Product Code: DTQ FDA UDI
GMDN Term: Cardiopulmonary bypass system, roller type 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Yes

FDA UDI

Category: Cardiopulmonary bypass system, roller type

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, roller type.

Variolock — LivaNova Deutschland GmbH · Class II
Venous Line Clamp — LivaNova Deutschland GmbH · Class II
HL 20 — Maquet Cardiopulmonary AG · Class II
SCP — LivaNova Deutschland GmbH · Class II
Accessories — LivaNova Deutschland GmbH · Class II
AVID TruCustom — AVID MEDICAL, INC. · Class II
ROTAFLOW — Maquet Cardiopulmonary AG · Class II
S5 Roller Pump 150 — LivaNova Deutschland GmbH · Class II

Cleared under the same submission

K151349 also covers:

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

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Manufacturer

Manufacturer: Terumo Cardiovascular Systems Corporation

Sources (1)

FDA UDI d57c820c-96b5-4b51-954b-614c810933ba 35 fields · synced Jun 9, 2026