AccessGUDID - DEVICE: CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS

GUDID

Device Identifier (DI) Information

Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC
Version or Model: 2800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 280029MM
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103021691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: No description.

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):
Over the Counter (OTC):
Kit:
Combination Product:
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60242	Aortic open-surgery heart valve bioprosthesis	A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DYE	replacement Heart-valve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P860057	001
P860057	004
P860057	019
P860057	023
P860057	030
P860057	036
P860057	039
P860057	045
P860057	051
P860057	053
P860057	062
P860057	100

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: MOUNTING DIAMETER (ANNULUS), 29 MILLIMETER

Device Record Status

Public Device Record Key: 489d5fef-58fb-4df1-8339-c7155678edd9
Public Version Date: May 22, 2025
Public Version Number: 5
DI Record Publish Date: August 30, 2014