OneTouch Verio 022-899

GUDID 20353885009762

OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters

LifeScan Europe GmbH

Glucose IVD, kit, electrometry
Primary Device ID20353885009762
NIH Device Record Key0816ce16-f291-440b-97c2-eaf6358a0f64
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Verio
Version Model Number022-899
Catalog Number022-899
Company DUNS480240820
Company NameLifeScan Europe GmbH
Device Count50
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

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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only
Special Storage Condition, SpecifyBetween 0 and 0 *Store your test strips in the vial only

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885009768 [Primary]
GS120353885009762 [Package]
Contains: 00353885009768
Package: Shipper case [24 Units]
In Commercial Distribution
NDC/NHRIC53885-271-50 [Secondary]
GS180353885009764 [Unit of Use]

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

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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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