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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 air bubble/fluid level detector FDA UDI
Device Name
The Air Bubble Detect (ABD) module is the interface between an air sensor and the system. The ABD module monitors the air sensor and communicates any alarms to the system. FDA UDI
Model / Reference
802110 FDA UDI
Description
The Air Bubble Detect (ABD) module is the interface between an air sensor and the system. The ABD module monitors the air sensor and communicates any alarms to the system. FDA UDI

Identifiers

Catalog Number
802110 FDA UDI
Primary DI / UDI-DI
00886799000700 FDA UDI
510(k) Number
K151349 FDA UDI
FDA Product Code
DTQ FDA UDI
GMDN Term
Cardiopulmonary bypass system air bubble/fluid level detector 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 air bubble/fluid level detector

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 air bubble/fluid level detector.

Cleared under the same submission

K151349 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 ec7073ae-a736-4151-81ef-1aad3c56f4c1 35 fields · synced Jun 9, 2026