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CDI™ Blood Parameter Monitoring System 500

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name
CDI™ Blood Parameter Monitoring System 500 FDA UDI
Generic Name
Cardiopulmonary bypass system mounting unit FDA UDI
Device Name
Interface cable for Meditronic Bio-Console 550 FDA UDI
Model / Reference
151861 FDA UDI
Description
Interface cable for Meditronic Bio-Console 550 FDA UDI

Identifiers

Catalog Number
151861 FDA UDI
Primary DI / UDI-DI
00886799000410 FDA UDI
510(k) Number
K133658 FDA UDI
FDA Product Code
DRY FDA UDI
GMDN Term
Cardiopulmonary bypass system mounting unit 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary bypass system mounting unit

CDI™ Blood Parameter Monitoring System 500 by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Cardiopulmonary bypass system mounting unit.

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 7843bf5c-aa84-46ff-a6e8-0be4b0f117a6 35 fields · synced Jun 9, 2026