AccessGUDID - DEVICE: CardiaMend (00850023375063)

GUDID

Device Identifier (DI) Information

Brand Name: CardiaMend
Version or Model: CMUS-10NS-0812
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CMUS-10NS-0812
Company Name: Helios Cardio Inc.

Primary DI Number: 00850023375063
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117912350 *Terms of Use

Device Description: CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35273	Cardiovascular patch, animal-derived	An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PSQ	Intracardiac Patch Or Pledget, Biologically Derived

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210331	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep Away from Excessive Heat

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Centimeter
Width: 12 Centimeter
Height: 1.0 Millimeter

Device Record Status

Public Device Record Key: 0d34bd57-0829-43a2-bd3c-f5689c5f1231
Public Version Date: December 21, 2022
Public Version Number: 1
DI Record Publish Date: December 13, 2022