AccessGUDID - DEVICE: FlexNav™ (05415067031389)

GUDID

Device Identifier (DI) Information

Brand Name: FlexNav™
Version or Model: FNAV-DS-LG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FNAV-DS-LG
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067031389
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Delivery System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
63283	Transcatheter heart valve bioprosthesis implantation catheter	A flexible tube intended to be used to deploy and implant a heart valve bioprosthesis (not included) during a minimally invasive transcatheter procedure via transarterial access (e.g., femoral, subclavian, aortic) under fluoroscopic guidance. It typically consists of a proximal handpiece with controls for positioning and deployment of the valve, and may be designed for deployment of a self-expanding bioprosthesis or include a balloon for dilation of an expandable bioprosthesis. This is a single-use device.	Active	false

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 19.0000 French
Length: 107.0000 Centimeter

Device Record Status

Public Device Record Key: 9d736d61-5baf-464d-a220-822df773f1f5
Public Version Date: September 28, 2021
Public Version Number: 1
DI Record Publish Date: September 20, 2021

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(855)478-5833
Email: customerservice@sjm.com

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