AccessGUDID - DEVICE: KONECT RESILIA (00690103201383)

GUDID

Device Identifier (DI) Information

Brand Name: KONECT RESILIA
Version or Model: 11060A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11060A23
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103201383
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: aortic valved conduit

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
60350	Aortic open-surgery heart valve bioprosthesis/synthetic polymer aorta graft	An implantable xenograft (e.g., porcine or bovine heart valve) fitted with a length of synthetic polymer blood vessel (vascular graft) intended to be implanted in the heart during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). It is processed to render the tissue in the valve non-viable while the attached synthetic blood vessel is designed to conform to the aortic root anatomy.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWR	Heart-Valve, Non-Allograft Tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150048	029

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 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 23MM

Device Record Status

Public Device Record Key: ecd6f95d-1242-4afd-80fc-a2777bacfd23
Public Version Date: May 22, 2025
Public Version Number: 4
DI Record Publish Date: July 17, 2020

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)822-9637
Email: tech_support@edwards.com

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