NOGA XP FG170000

GUDID 10846835011678

NOGA XP-Cardiac Mapping System

BIOSENSE WEBSTER (ISRAEL) LTD.

Cardiac mapping system
Primary Device ID10846835011678
NIH Device Record Key098c5932-075c-4a17-814a-12eb3e19d327
Commercial Distribution Discontinuation2020-10-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNOGA XP
Version Model NumberFG170000
Catalog NumberFG170000
Company DUNS514556950
Company NameBIOSENSE WEBSTER (ISRAEL) LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com
Phone+1(866)473-7823
Emailtechsupport@its.jnj.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110846835011678 [Primary]

FDA Product Code

DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-15
Device Publish Date2016-09-24

Devices Manufactured by BIOSENSE WEBSTER (ISRAEL) LTD.

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10846835011678 - NOGA XP2021-10-15NOGA XP-Cardiac Mapping System
10846835011678 - NOGA XP2021-10-15 NOGA XP-Cardiac Mapping System
10846835018639 - TruDi™ Navigation System2021-05-12 TruDi™ Navigation System
10846835000870 - CARTO 32019-11-08 CARTO 3

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