Navitor™ NVRO-25

GUDID 05415067045782

Transcatheter Heart Valve

ST. JUDE MEDICAL, INC.

Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework Aortic transcatheter heart valve bioprosthesis, stent-like framework

• Primary Device ID: 05415067045782
• NIH Device Record Key: 443527d3-68a3-4e3b-9527-fe7971a1281e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navitor™
• Version Model Number: NVRO-25
• Catalog Number: NVRO-25
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

Device Dimensions

• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067045782 [Primary]

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: 2023-10-09
• Device Publish Date: 2023-09-29

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• 05415067045775: Transcatheter Heart Valve
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• 05415067031594: Transcatheter Heart Valve
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