NOGA XP FG170000

GUDID 10846835011678

NOGA XP-Cardiac Mapping System

BIOSENSE WEBSTER (ISRAEL) LTD.

Cardiac mapping system

• Primary Device ID: 10846835011678
• NIH Device Record Key: 098c5932-075c-4a17-814a-12eb3e19d327
• Commercial Distribution Discontinuation: 2020-10-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NOGA XP
• Version Model Number: FG170000
• Catalog Number: FG170000
• Company DUNS: 514556950
• Company Name: BIOSENSE WEBSTER (ISRAEL) LTD.
• 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(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com
• Phone: +1(866)473-7823
• Email: techsupport@its.jnj.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835011678 [Primary]

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-15
• Device Publish Date: 2016-09-24

Devices Manufactured by BIOSENSE WEBSTER (ISRAEL) LTD.

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• 10846835011678 - NOGA XP: 2021-10-15NOGA XP-Cardiac Mapping System
• 10846835011678 - NOGA XP: 2021-10-15 NOGA XP-Cardiac Mapping System
• 10846835018639 - TruDi™ Navigation System: 2021-05-12 TruDi™ Navigation System
• 10846835000870 - CARTO 3: 2019-11-08 CARTO 3