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: The RS-232 Interface Module provides the interface between the RS-232 protocol data acquistion software and the system. The module outputs system data to the data acquisition software such as Tlink Data management Software. FDA UDI
Model / Reference: 802113 FDA UDI
Description: The RS-232 Interface Module provides the interface between the RS-232 protocol data acquistion software and the system. The module outputs system data to the data acquisition software such as Tlink Data management Software. FDA UDI

Identifiers

Catalog Number: 802113 FDA UDI
Primary DI / UDI-DI: 00886799000731 FDA UDI
510(k) Number: K151349 FDA UDI
FDA Product Code: DWB FDA UDI
DTQ FDA UDI
GMDN Term: Cardiopulmonary bypass system, roller type FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4370 FDA UDI
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 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.

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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 d4c3a883-c959-4829-9644-3d61903036a1 35 fields · synced Jun 9, 2026