Custodiol(R)

FDA UDI

Class II (US FDA UDI)

by Dr. Franz Köhler Chemie GmbH

Identity

Trade Name: Custodiol(R) FDA UDI
Generic Name: Donor-organ/tissue/cell preservation solution FDA UDI
Model / Reference: 2 x 5000 ml FDA UDI

Identifiers

Primary DI / UDI-DI: 04033133250000 FDA UDI
510(k) Number: K020924 FDA UDI
K032794 FDA UDI
K043461 FDA UDI
K992209 FDA UDI
FDA Product Code: KDL FDA UDI
MSB FDA UDI
KDN FDA UDI
GMDN Term: Donor-organ/tissue/cell preservation solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5880 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: Donor-organ/tissue/cell preservation solution

Custodiol(R) by Dr. Franz Köhler Chemie GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K020924 also covers:

K032794 also covers:

K043461 also covers:

K992209 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: Dr. Franz Köhler Chemie GmbH

Sources (1)

FDA UDI 48fc2905-ddd1-4457-a125-2e632528c891 34 fields · synced May 30, 2026