OneTouch Verio 022-657

GUDID 20353885008710

OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.

LifeScan Europe GmbH

Glucose analyser IVD, home-use
Primary Device ID20353885008710
NIH Device Record Key43e67605-5523-4b5d-806a-d3eb3eb8b88e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Verio
Version Model Number022-657
Catalog Number022-657
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

Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge

Operating and Storage Conditions

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885008716 [Primary]
GS120353885008710 [Package]
Contains: 00353885008716
Package: Shipper case [4 Units]
In Commercial Distribution
NDC/NHRIC53885-657-01 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-26
Device Publish Date2017-09-13

On-Brand Devices [OneTouch Verio]

20353885011550OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. Fo
20353885010485OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood gluco
20353885010034OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood gluco
20353885009762OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou
20353885009755OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou
20353885008734OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing Fo
20353885008727OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing Fo
20353885008710OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing Fo
20353885007737OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou
20353885007720OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTou
20353885012038OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For
20353885007775OneTouch Verio®Level 4 Control Solution
53885-273-02OneTouch Verio®Level 3 Control Solution
20353885012182OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For
20353885012427OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For
20353885012595OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For
20353885012618OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For

Trademark Results [OneTouch Verio]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONETOUCH VERIO
ONETOUCH VERIO
77510844 4112124 Live/Registered
LIFESCAN IP HOLDINGS, LLC
2008-06-30

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