DEVICE: CardiaMend (00850023375032)

Device Identifier (DI) Information

CardiaMend
CMUS-10NS-1015
In Commercial Distribution
CMUS-10NS-1015
Helios Cardio Inc.
00850023375032
GS1

1
117912350 *Terms of Use
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 10 x 15 cm
CLOSE

Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
PSQ Intracardiac Patch Or Pledget, Biologically Derived
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K210331 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
Length: 10 Centimeter
Width: 15 Centimeter
Height: 1 Millimeter
CLOSE

Device Record Status

66b2085b-3576-4274-aad4-74a5df14af2d
February 09, 2022
1
February 01, 2022
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-339-707-7788
support@helioscardio.com
CLOSE