Cardiovascular Procedure Kit

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name: Cardiovascular Procedure Kit FDA UDI
Generic Name: Cardioplegia solution administration kit FDA UDI
Model / Reference: 76436 FDA UDI

Identifiers

Primary DI / UDI-DI: 00699753505681 FDA UDI
510(k) Number: K823451 FDA UDI
FDA Product Code: DTR FDA UDI
GMDN Term: Cardioplegia solution administration kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4240 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardioplegia solution administration kit

Cardiovascular Procedure Kit by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K823451 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 fc8c81bd-22d7-4915-ba7d-efa23d0e4319 33 fields · synced Jun 9, 2026