CardioGRAFT-MC™

Basic Information

• Brand Name: CardioGRAFT-MC™
• Primary DI: 00889858618656
• Version / Model: DPPGN4027
• Catalog Number: DPPGN
• Company Name: LIFENET HEALTH
• Labeler DUNS: 121828156
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-27
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: bae3df0f-02ad-4ca1-b2df-8a61118a1f3f

Device Description

Decellularized Pulmonary Artery Patch - Thin

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	870.3470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61625	Cadaveric pulmonary artery bioprosthesis	An implantable heart tissue allograft obtained from a human cadaver intended to be implanted in the heart during open heart surgery, to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and treated to render the tissue decellularized. It may be supplied in various configurations including pulmonary hemi-artery, pulmonary trunk and pulmonary branch.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889858618656	GS1

Device Sizes

Type	Value	Unit	Text
Length	40	Millimeter
Width	27	Millimeter