Belzer UW Cold Storage Solution

FDA UDI

Class II (US FDA UDI)

by Bridge to Life Ltd

Identity

Trade Name: Belzer UW Cold Storage Solution FDA UDI
Generic Name: Donor-organ/tissue/cell preservation solution FDA UDI
Device Name: For flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. 1000mL FDA UDI
Model / Reference: BUW-006 FDA UDI
Description: For flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. 1000mL FDA UDI

Identifiers

Primary DI / UDI-DI: 00198715358155 FDA UDI
510(k) Number: K243384 FDA UDI
FDA Product Code: KDN FDA UDI
KDL 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

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

Dimensions & Sizes

Size: Total Volume — 1000 Milliliter FDA UDI

Category: Donor-organ/tissue/cell preservation solution

Belzer UW Cold Storage Solution by Bridge to Life Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Donor-organ/tissue/cell preservation solution.

Custodiol(R) — Dr. Franz Köhler Chemie GmbH · Class II
Custodiol(R) — Dr. Franz Köhler Chemie GmbH · Class II
Custodiol — Dr. Franz Köhler Chemie GmbH · Class II
Belzer MPS (UW Machine Perfusion Solution ) — PRESERVATION SOLUTIONS, INC. · Class II
X°Port Lung Preservation Solution — Traferox Technologies, Inc. · Class II
STEEN Solution™ — XVIVO PERFUSION, INC. · Class III
Custodiol(R) — Dr. Franz Köhler Chemie GmbH · Class II
PARAGON-W (UW solution) — INSTITUT GEORGES LOPEZ · Class II

Cleared under the same submission

K243384 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bridge to Life Ltd

Sources (1)

FDA UDI 4bc850ac-caaa-4b57-8b7b-85569e4799a2 36 fields · synced Jun 1, 2026