OneTouch Verio Blood Glucose Monitoring System. 02404201

GUDID 20353885011819

OneTouch Verio Blood Glucose Monitoring System.

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use
Primary Device ID20353885011819
NIH Device Record Key1ab1da67-079d-4134-bc1b-1d6c5577508f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Verio Blood Glucose Monitoring System.
Version Model Number024042
Catalog Number02404201
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

Phone8885673003
EmailXX@XX.XX

Device Dimensions

Needle Gauge30 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885011815 [Primary]
GS120353885011819 [Package]
Contains: 00353885011815
Package: shipper case [10 Units]
In Commercial Distribution
NDC/NHRIC53885-042-01 [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 Date2019-03-21
Device Publish Date2019-03-13

On-Brand Devices [OneTouch Verio Blood Glucose Monitoring System.]

20353885011819OneTouch Verio Blood Glucose Monitoring System.
20353885011802OneTouch Verio Blood Glucose Monitoring System.

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