Custodiol(R)

GUDID 04033133105003

Dr. Franz Köhler Chemie GmbH

Donor-organ preservation solution
Primary Device ID04033133105003
NIH Device Record Keyc838a8dd-b584-4209-9ad9-283200ca02d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustodiol(R)
Version Model Number10 x 500 ml
Company DUNS316512953
Company NameDr. Franz Köhler Chemie GmbH
Device Count10
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light

Device Identifiers

Device Issuing AgencyDevice ID
GS104033133005006 [Unit of Use]
GS104033133105003 [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 Date2019-05-17
Device Publish Date2019-05-09

On-Brand Devices [Custodiol(R)]

040331336100026 x 1000 ml
040331334200074 x 2000 ml
040331332500002 x 5000 ml
0403313310500310 x 500 ml
040331336110166 x 1000 ml
040331330200094 x 2000 ml

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