CardiaMend CMUS-05NS-0812

GUDID 00850023375049

CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm

Helios Cardio Inc.

Cardiovascular patch, animal-derived

• Primary Device ID: 00850023375049
• NIH Device Record Key: 9e3025d2-27e8-4316-8ecb-251b35071a41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardiaMend
• Version Model Number: CMUS-05NS-0812
• Catalog Number: CMUS-05NS-0812
• Company DUNS: 117912350
• Company Name: Helios Cardio Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com
• Phone: 1-339-707-7788
• Email: support@helioscardio.com

Device Dimensions

• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter
• Length: 8 Centimeter
• Width: 12 Centimeter
• Height: 0.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Excessive Heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850023375049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210331

FDA Product Code

• PSQ: Intracardiac Patch Or Pledget, Biologically Derived

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: 2022-02-09
• Device Publish Date: 2022-02-01

On-Brand Devices [CardiaMend]

• 00850023375056: CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 4 x 7 cm
• 00850023375049: CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
• 00850023375032: CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 10 x 15 cm
• 00850023375025: CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
• 00850023375018: CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm
• 00850023375001: CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 6 x 12 cm
• 00850023375087: CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm