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CDI™ H/S Cuvette 1/2 x 1/2

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name
CDI™ H/S Cuvette 1/2 x 1/2 FDA UDI
Generic Name
Cardiopulmonary bypass system blood gas sensor FDA UDI
Model / Reference
6912 FDA UDI

Identifiers

Primary DI / UDI-DI
00699753270145 FDA UDI
510(k) Number
K133658 FDA UDI
FDA Product Code
DRY FDA UDI
GMDN Term
Cardiopulmonary bypass system blood gas sensor 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

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary bypass system blood gas sensor

CDI™ H/S Cuvette 1/2 x 1/2 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 gas sensor.

Cleared under the same submission

K133658 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 d7cf3ba8-f72f-47a9-9ce1-ce5d3e591713 33 fields · synced Jun 9, 2026