NuVision Connector Cable

GUDID 00860005688111

The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system.

Nuvera Medical, Inc.

Cardiac mapping/ultrasound imaging catheter

• Primary Device ID: 00860005688111
• NIH Device Record Key: f7518071-741e-4586-a115-eea6871c66df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuVision Connector Cable
• Version Model Number: FG10594
• Company DUNS: 117379819
• Company Name: Nuvera 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damage
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005688111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201775

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-15
• Device Publish Date: 2021-07-07

Devices Manufactured by Nuvera Medical, Inc.

• 00860005688104 - NuVision ICE Catheter: 2021-07-15 The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use.
• 00860005688111 - NuVision Connector Cable: 2021-07-15The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system.
• 00860005688111 - NuVision Connector Cable: 2021-07-15 The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision IC