OneTouch Ultra2 02404601

GUDID 20353885011857

OneTouch Ultra2 Blood Glucose Monitoring System.

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use
Primary Device ID20353885011857
NIH Device Record Key83d6edaa-3d6b-42c6-b33a-3d33892e9f57
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Ultra2
Version Model Number024-046
Catalog Number02404601
Company DUNS480240820
Company NameLifeScan Europe GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX

Device Dimensions

Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge30 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885011853 [Primary]
GS120353885011857 [Package]
Contains: 00353885011853
Package: shipper case [4 Units]
In Commercial Distribution
NDC/NHRIC53885-046-01 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-20
Device Publish Date2019-03-12

On-Brand Devices [OneTouch Ultra2]

20353885010515OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip.
20353885010010OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip. Not f
20353885008857OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or re
20353885008376OneTouch Ultra2 Blood Glucose Monitoring Meter - Warranty replacement
20353885000271OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra
20353885011857OneTouch Ultra2 Blood Glucose Monitoring System.

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