Belzer UW Cold Storage Solution

Basic Information

• Brand Name: Belzer UW Cold Storage Solution
• Primary DI: 00198715358155
• Version / Model: BUW-006
• Company Name: Bridge To Life Ltd.
• Labeler DUNS: 830330457
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-17
• Public Version: 1
• Public Version Date: 2025-06-25
• Public Version Status: New
• Public Device Record Key: 4bc850ac-caaa-4b57-8b7b-85569e4799a2

Device 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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	876.5880	2
KDL	Set, Perfusion, Kidney, Disposable	Gastroenterology, Urology	876.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18004	Donor-organ/tissue/cell preservation solution	A solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00199284309944	GS1		10	In Commercial Distribution
Primary	00198715358155	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243384	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1000	Milliliter