Custodiol(R)

GUDID 04033133105003

Dr. Franz Köhler Chemie GmbH

Donor-organ preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution

• Primary Device ID: 04033133105003
• NIH Device Record Key: c838a8dd-b584-4209-9ad9-283200ca02d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custodiol(R)
• Version Model Number: 10 x 500 ml
• Company DUNS: 316512953
• Company Name: Dr. Franz Köhler Chemie GmbH
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 35.6 Degrees Fahrenheit and 46.4 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light

Device Identifiers

Device Issuing Agency	Device ID
GS1	04033133005006 [Unit of Use]
GS1	04033133105003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020924

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-17
• Device Publish Date: 2019-05-09

On-Brand Devices [Custodiol(R)]

• 04033133610002: 6 x 1000 ml
• 04033133420007: 4 x 2000 ml
• 04033133250000: 2 x 5000 ml
• 04033133105003: 10 x 500 ml
• 04033133611016: 6 x 1000 ml
• 04033133020009: 4 x 2000 ml