AccessGUDID - DEVICE: Evolut™ FX+ (00763000716127)

GUDID

Device Identifier (DI) Information

Brand Name: Evolut™ FX+
Version or Model: EVFXPLUS-23
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC COREVALVE LLC

Primary DI Number: 00763000716127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079527231 *Terms of Use

Device Description: TAV EVFXPLUS-23 COMM 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:	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
NPT	Aortic valve, prosthesis, percutaneously delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P130021	155

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: Keep away from sunlight
Storage Environment Temperature: more than 0 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 23 MM

Device Record Status

Public Device Record Key: 2289329a-4929-4774-83ab-fc9caa98637c
Public Version Date: May 13, 2024
Public Version Number: 1
DI Record Publish Date: May 03, 2024

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: Yes
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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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