FlexNav™ FNAV-DS-LG

GUDID 05415067031389

Delivery System

ST. JUDE MEDICAL, INC.

Transcatheter heart valve bioprosthesis implantation catheter

• Primary Device ID: 05415067031389
• NIH Device Record Key: 9d736d61-5baf-464d-a220-822df773f1f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexNav™
• Version Model Number: FNAV-DS-LG
• Catalog Number: FNAV-DS-LG
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter
• Catheter Gauge: 19 French
• Length: 107 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067031389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190023

FDA Product Code

• NPT: Aortic valve, prosthesis, percutaneously delivered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-28
• Device Publish Date: 2021-09-20

On-Brand Devices [FlexNav™]

• 05415067031440: Loading System
• 05415067031433: Loading System
• 05415067031389: Delivery System
• 05415067031372: Delivery System