CardioCel Closure Cardiovascular Patch C0614C

GUDID 09348992000631

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 Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived

• Primary Device ID: 09348992000631
• NIH Device Record Key: 1ada9309-bac3-479e-be0c-e319daaf979c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioCel Closure Cardiovascular Patch
• Version Model Number: UC0614C
• Catalog Number: C0614C
• 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: 14 Centimeter
• Length: 6 Centimeter
• Width: 14 Centimeter
• Length: 6 Centimeter
• Width: 14 Centimeter
• Length: 6 Centimeter
• Width: 14 Centimeter
• Length: 6 Centimeter
• Width: 14 Centimeter
• Length: 6 Centimeter
• Width: 14 Centimeter
• Length: 6 Centimeter
• Width: 14 Centimeter
• Length: 6 Centimeter
• Width: 14 Centimeter
• Length: 6 Centimeter
• Width: 14 Centimeter
• Length: 6 Centimeter
• Width: 14 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	09348992000631 [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: 2020-04-24
• Device Publish Date: 2020-04-16

Devices Manufactured by ADMEDUS REGEN PTY LTD

• 09348992000006 - CardioCel: 2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
• 09348992000013 - CardioCel: 2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
• 09348992000020 - CardioCel: 2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
• 09348992000037 - CardioCel: 2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP tech
• 09348992000082 - CardioCel: 2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
• 09348992000105 - CardioCel VSD: 2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
• 09348992000143 - CardioCel Neo: 2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
• 09348992000150 - CardioCel Neo: 2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn