OneTouch Ultramini 021-422

GUDID 20353885001315

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip

LifeScan Europe GmbH

Glucose analyser IVD, home-use
Primary Device ID20353885001315
NIH Device Record Key2405e733-3e9d-4d49-9b72-ee5d99dc213c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Ultramini
Version Model Number021-422
Catalog Number021-422
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(800)227-8862
EmailXX@XX.XX

Device Dimensions

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

Operating and Storage Conditions

Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit
Handling Environment TemperatureBetween 43 Degrees Fahrenheit and 111 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885001311 [Primary]
GS120353885001315 [Package]
Contains: 00353885001311
Package: Shipper case [10 Units]
In Commercial Distribution
NDC/NHRIC53885-422-01 [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 Ultramini]

20353885011468OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
20353885008161OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
20353885008130OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
20353885002688OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or
20353885002671OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ult
20353885001315OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or
20353885001285OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ult
20353885000516OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or
20353885000486OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or

Trademark Results [OneTouch Ultramini]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONETOUCH ULTRAMINI
ONETOUCH ULTRAMINI
76661412 3402295 Dead/Cancelled
JOHNSON & JOHNSON
2006-06-12
ONETOUCH ULTRAMINI
ONETOUCH ULTRAMINI
76661411 3405923 Dead/Cancelled
JOHNSON & JOHNSON
2006-06-12

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