OneTouch Verio IQ 022-268

GUDID 20353885007713

OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use
Primary Device ID20353885007713
NIH Device Record Key249266ad-1259-4e61-b6cf-1df314be2eee
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Verio IQ
Version Model Number022-268
Catalog Number022-268
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(888)567-3003
EmailXX@XX.XX

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885007719 [Primary]
GS120353885007713 [Package]
Contains: 00353885007719
Package: Shipper case [10 Units]
In Commercial Distribution
NDC/NHRIC53885-854-01 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose dehydrogenase, glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-26
Device Publish Date2017-09-13

On-Brand Devices [OneTouch Verio IQ]

20353885008406OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing
20353885007713OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing
20353885007706OneTouch Verio IQ Blood Glucose Monitoring System. For In vitro diagnostic use. For self-testing

Trademark Results [OneTouch Verio IQ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONETOUCH VERIO IQ
ONETOUCH VERIO IQ
85067643 4122419 Live/Registered
JOHNSON & JOHNSON
2010-06-21

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