EZ Steer ThermoCool NAV BNI75TCDFH

GUDID 10846835003338

BIOSENSE WEBSTER INC.

Cardiac radio-frequency ablation system catheter

• Primary Device ID: 10846835003338
• NIH Device Record Key: 22523cf0-29f2-4f06-8932-12ed6ab13b43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ Steer ThermoCool NAV
• Version Model Number: BNI75TCDFH
• Catalog Number: BNI75TCDFH
• 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: 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(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
• 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
• 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 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835003338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030031

FDA Product Code

• OAD: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-09-27
• Device Publish Date: 2014-09-10

On-Brand Devices [EZ Steer ThermoCool NAV]

• 10846835003390: BNI75TCJJH
• 10846835003376: BNI75TCFJH
• 10846835003352: BNI75TCFFH
• 10846835003338: BNI75TCDFH
• 10846835003314: BNI75TCDDH