TX eco Cable D140102

GUDID 10846835017427

TX eco Cable Kit

Biosense Webster Inc

Electrical-only medical device connection cable, reusable

• Primary Device ID: 10846835017427
• NIH Device Record Key: 73097460-3c52-4976-822a-7354c0fea44a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TX eco Cable
• Version Model Number: D140102
• Catalog Number: D140102
• Company DUNS: 020163218
• Company Name: Biosense Webster 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from Sunlight
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835017427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210027

FDA Product Code

• LPB: Cardiac ablation percutaneous catheter

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: 2023-07-31
• Device Publish Date: 2023-07-21

Devices Manufactured by Biosense Webster Inc

• 10846835022780 - SOUNDSTAR CRYSTAL Ultrasound Catheter: 2024-07-04 SOUNDSTAR CRYSTAL Ultrasound Catheter
• 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: 2023-07-31TX eco Cable Kit
• 10846835017427 - TX eco Cable: 2023-07-31 TX eco Cable Kit
• 10846835017434 - TX eco Cable Dongle Spare Part: 2023-07-31 TX eco Cable Dongle Spare Part
• 10846835020229 - LASSOSTAR Non-NAV -Circular navigation catheter: 2023-07-27 2.44FR LASSOSTAR non-NAV,10P,20MM
• 10846835020236 - LASSOSTAR Non-NAV -Circular navigation catheter: 2023-07-27 2.44FR LASSOSTAR non-NAV,10P,15MM