Custodiol

GUDID 40331330610002

Dr. Franz Köhler Chemie GmbH

Donor-organ preservation solution

• Primary Device ID: 40331330610002
• NIH Device Record Key: 51abee3f-7aef-434d-b223-937e83929f91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custodiol
• Version Model Number: 6 x 1000 ml
• Company DUNS: 316512953
• Company Name: Dr. Franz Köhler Chemie GmbH
• Device Count: 6
• 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 Degrees Fahrenheit and 59 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 59 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04033133001000 [Unit of Use]
GS1	40331330610002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020924

FDA Product Code

• MSB: System And Accessories, Isolated Heart, Transport And Preservation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Custodiol]

• 40331330610002: 6 x 1000 ml
• 40331330420007: 4 x 2000 ml
• 40331330250000: 2 x 5000 ml
• 40331330105003: 10 x 500 ml
• 40331330050006: 5000 ml