DigniCool REF 11000

GUDID 07350002100080

Dignitana AB

Scalp cooling system

• Primary Device ID: 07350002100080
• NIH Device Record Key: c5f9d907-0049-447f-8a25-f18d85d9a329
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DigniCool
• Version Model Number: 5L
• Catalog Number: REF 11000
• Company DUNS: 775901619
• Company Name: Dignitana AB
• Device Count: 1
• 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: false
• 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

Customer Support Contacts

• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com

Device Dimensions

• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350002100080 [Primary]

FDA Product Code

• PMC: Scalp Cooling System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-01

On-Brand Devices [DigniCool]

• 07350002100097: 0.5L
• 07350002100080: 5L