AccessGUDID - DEVICE: EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM) (00690103210873)

GUDID

Device Identifier (DI) Information

Brand Name: EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM)
Version or Model: 9630PL29A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9630PL29A
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103210873
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: SAPIEN 3 PULMONIC DELIVERY SYSTEM - 29MM (US)

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:	Yes
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?
60247	Pulmonary transcatheter heart valve bioprosthesis	An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is designed to be implanted with a catheter via vascular access. It may be attached to an expandable metal framework which may be expanded with a balloon or self-expand, and may include other material types (e.g., synthetic polymer). Devices associated with implantation (e.g., catheter, introducer) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPV	Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200015	011

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
Special Storage Condition, Specify: Store in a cool, dry place

Clinically Relevant Size

[?]

Size Type Text
Balloon Diameter: 29.0000 Millimeter

Device Record Status

Public Device Record Key: d4e073af-1e81-427e-843f-fa58a34d7eff
Public Version Date: January 12, 2022
Public Version Number: 1
DI Record Publish Date: January 04, 2022