NUVISION NAV Ultrasound Catheter FG11656

GUDID 10846835025194

NUVISION NAV Ultrasound Catheter, 10F

Biosense Webster Inc

Intracardiac ultrasound imaging catheter, steerable, single-use

• Primary Device ID: 10846835025194
• NIH Device Record Key: 9af900e2-e6bc-49bb-b549-30ceff37dad4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NUVISION NAV Ultrasound Catheter
• Version Model Number: FG11656
• Catalog Number: FG11656
• Company DUNS: 020163218
• Company Name: Biosense Webster Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)
• Special Storage Condition, Specify: Between 0 and 0 *Liquid-tight (catheter shaft only)
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Protection against vertically dripping water drops (catheter handle only)

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835025194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223766

FDA Product Code

• OBJ: Catheter, ultrasound, intravascular

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: 2023-07-11
• Device Publish Date: 2023-07-03

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• 10846835016796 - TX eco EXT Cable: 2023-10-12 TX eco EXT Cable
• 10846835025811 - OPTRELL Mapping Catheter with TRUEref Technology: 2023-10-12 OPTRELL-36 F-J Curve
• 10846835025828 - OPTRELL Mapping Catheter with TRUEref Technology: 2023-10-12 OPTRELL-36 D-F Curve
• 10846835017427 - TX eco Cable: 2023-07-31 TX eco Cable Kit