AccessGUDID - DEVICE: SAPIEN 3 Ultra System (00690103207811)

GUDID

Device Identifier (DI) Information

Brand Name: SAPIEN 3 Ultra System
Version or Model: 9750CM20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9750CM20A
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103207811
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: SAPIEN 3 Ultra valve with Commander Delivery System

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?
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
NPU	Prosthesis, Mitral Valve, Percutaneously Delivered
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140031	091
P140031	104
P140031	107
P140031	112
P140031	182

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: The delivery system should be stored in a cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 20.0000 Millimeter

Device Record Status

Public Device Record Key: bec164a8-3b93-465a-82cc-ffd56ae6f400
Public Version Date: May 02, 2025
Public Version Number: 7
DI Record Publish Date: August 30, 2019

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: Yes
Serial Number: No
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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