Belzer UW Cold Storage Solution

GUDID 10810805000047

Formulated for flushing and cold storage of kidney, liver, pancreas organs. 1000mL

PRESERVATION SOLUTIONS INC

Donor-organ preservation solution
Primary Device ID10810805000047
NIH Device Record Key3eb723bb-7924-4393-8b2e-dea79daf1e8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBelzer UW Cold Storage Solution
Version Model NumberBUW-001
Company DUNS090266979
Company NamePRESERVATION SOLUTIONS INC
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

Phone2627236715
Emailbrader@preservationsolutions.com
Phone2627236715
Emailbrader@preservationsolutions.com
Phone2627236715
Emailbrader@preservationsolutions.com
Phone2627236715
Emailbrader@preservationsolutions.com
Phone2627236715
Emailbrader@preservationsolutions.com
Phone2627236715
Emailbrader@preservationsolutions.com
Phone2627236715
Emailbrader@preservationsolutions.com
Phone2627236715
Emailbrader@preservationsolutions.com
Phone2627236715
Emailbrader@preservationsolutions.com
Phone2627236715
Emailbrader@preservationsolutions.com

Device Dimensions

Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter
Total Volume1000 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810805000040 [Primary]
GS110810805000047 [Package]
Contains: 00810805000040
Package: [10 Units]
In Commercial Distribution

FDA Product Code

KDNSystem, Perfusion, Kidney

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-07

On-Brand Devices [Belzer UW Cold Storage Solution ]

10810805000078Formulated for flushing and cold storage of kidney, liver and pancreas organs. 2000 mL
10810805000047Formulated for flushing and cold storage of kidney, liver, pancreas organs. 1000mL
10810805000023Formulated for flushing and cold storage of kidney, liver and pancreas organs. 500 mL

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