OneTouch Ultra Plus

GUDID 20353885012632

OneTouch Ultra® Plus strips work with OneTouch Ultra Plus Flex(TM) meter.

LifeScan Europe GmbH

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Primary Device ID20353885012632
NIH Device Record Key4fd5abb9-a396-4a69-ac29-53bbc3a66d4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Ultra Plus
Version Model Number024-271
Company DUNS480240820
Company NameLifeScan Europe GmbH
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx
Phone1 888 567-3003
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885012638 [Primary]
GS120353885012632 [Package]
Contains: 00353885012638
Package: Shipper [24 Units]
In Commercial Distribution
GS180353885012634 [Unit of Use]

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-08
Device Publish Date2022-08-31

On-Brand Devices [OneTouch Ultra Plus]

20353885012687OneTouch Ultra Plus™ Level 4 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.
80353885012641OneTouch Ultra Plus™ Level 3 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.
20353885012632OneTouch Ultra® Plus strips work with OneTouch Ultra Plus Flex(TM) meter.

Trademark Results [OneTouch Ultra Plus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONETOUCH ULTRA PLUS
ONETOUCH ULTRA PLUS
97350212 not registered Live/Pending
LifeScan IP Holdings, LLC
2022-04-06

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