LASSOSTAR Non-NAV -Circular navigation catheter D139002

GUDID 10846835020229

2.44FR LASSOSTAR non-NAV,10P,20MM

Biosense Webster Inc

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• Primary Device ID: 10846835020229
• NIH Device Record Key: c3f9dfba-ce74-49c6-bbc1-47b2fc16704b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LASSOSTAR Non-NAV -Circular navigation catheter
• Version Model Number: D139002
• Catalog Number: D139002
• 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: 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

Operating and Storage Conditions

• 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from 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 damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if use if box is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835020229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193632

FDA Product Code

• DRF: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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: 2023-07-27
• Device Publish Date: 2023-07-19

On-Brand Devices [LASSOSTAR Non-NAV -Circular navigation catheter]

• 10846835020243: 2.44FR LASSOSTAR non-NAV,10P,25MM
• 10846835020236: 2.44FR LASSOSTAR non-NAV,10P,15MM
• 10846835020229: 2.44FR LASSOSTAR non-NAV,10P,20MM