CardioCel Cardiovascular Patch C0404

GUDID 09348992000594

CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture

ADMEDUS REGEN PTY LTD

Cardiovascular patch, animal-derived

• Primary Device ID: 09348992000594
• NIH Device Record Key: f1aec9f2-84b1-42a1-a819-4beb2cfcf122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioCel Cardiovascular Patch
• Version Model Number: UC0404
• Catalog Number: C0404
• Company DUNS: 741172167
• Company Name: ADMEDUS REGEN PTY LTD
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com

Device Dimensions

• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter
• Length: 4 Centimeter
• Width: 4 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348992000594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130872

FDA Product Code

• DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [CardioCel Cardiovascular Patch]

• 09348992000617: CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
• 09348992000587: CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
• 09348992000594: CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.