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CDI OneView™ Monitoring System

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name
CDI OneView™ Monitoring System FDA UDI
Generic Name
Cardiopulmonary bypass system blood tubing set FDA UDI
Device Name
CDI OneView™ Calibration Gas 1 FDA UDI
Model / Reference
CDI746 FDA UDI
Description
CDI OneView™ Calibration Gas 1 FDA UDI

Identifiers

Catalog Number
CDI746 FDA UDI
Primary DI / UDI-DI
10886799001865 FDA UDI
510(k) Number
K234065 FDA UDI
FDA Product Code
DRY FDA UDI
GMDN Term
Cardiopulmonary bypass system blood tubing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4330 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary bypass system blood tubing set

CDI OneView™ Monitoring System 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 blood tubing set.

Cleared under the same submission

K234065 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 10261e94-ad95-49c9-a59a-6c1bd1863e1b 36 fields · synced Jun 9, 2026