AccessGUDID - DEVICE: EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV) (00690103187823)

GUDID

Device Identifier (DI) Information

Brand Name: EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV)
Version or Model: 9000TFX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9000TFX26A
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103187823
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2017
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):	No
Over the Counter (OTC):	No
Kit:
Combination Product:
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?
60245	Aortic transcatheter heart valve bioprosthesis, stent-like framework	An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPT	Aortic valve, prosthesis, percutaneously delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 26 MILIMETER DIAMETER EXPANDED VALVE

Device Record Status

Public Device Record Key: 2f49cb0a-42fc-46ae-afd9-0d316eddf189
Public Version Date: June 29, 2023
Public Version Number: 5
DI Record Publish Date: August 30, 2014