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 pump FDA UDI
Device Name: Roller Pump (4" Blue). The small roller pump is a peristaltic pump with a 4 inch (10 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universal tub clamp mechanism accommodates a variety of tubing sizes, including dual tube sets. FDA UDI
Model / Reference: 801040 FDA UDI
Description: Roller Pump (4" Blue). The small roller pump is a peristaltic pump with a 4 inch (10 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universal tub clamp mechanism accommodates a variety of tubing sizes, including dual tube sets. FDA UDI

Identifiers

Catalog Number: 801040 FDA UDI
Primary DI / UDI-DI: 00886799000533 FDA UDI
510(k) Number: K151349 FDA UDI
FDA Product Code: DTQ FDA UDI
GMDN Term: Cardiopulmonary bypass system roller pump 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary bypass system roller pump

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 pump.

Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Terumo Cardiovascular Systems Corporation

Sources (1)

FDA UDI 8792ff40-32b2-4d77-9e43-a8f3631c7e1d 35 fields · synced Jun 9, 2026