Belzer UW Cold Storage Solution

GUDID 00199284210417

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. 2000mL

Bridge To Life Ltd.

Donor-organ/tissue/cell preservation solution
Primary Device ID00199284210417
NIH Device Record Key8855a979-ebb8-483a-9a00-a6cb44fd83c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBelzer UW Cold Storage Solution
Version Model NumberBUW-006
Company DUNS830330457
Company NameBridge To Life Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com
Phone(803) 545-0080
Emailorders@B2LL.com

Device Dimensions

Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100199284210417 [Package]
Contains: 00199284914773
Package: [5 Units]
In Commercial Distribution
GS100199284914773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDNSystem, Perfusion, Kidney

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-25
Device Publish Date2025-06-17

On-Brand Devices [Belzer UW Cold Storage Solution]

00199284210417For flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal
00199284590434For flushing and cold storage of kidney, liver, and pancreas organs at the time of organ removal
00199284309944For flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal

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