OneTouch Ultrasoft

GUDID 20353885012441

OneTouch Ultrasoft Lancets

LifeScan Europe GmbH

Glucose monitoring system IVD, point-of-care
Primary Device ID20353885012441
NIH Device Record Key260a47c1-c4db-4263-8f30-5ed49da6fbdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Ultrasoft
Version Model Number011-423
Company DUNS480240820
Company NameLifeScan Europe GmbH
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX
Phone8002278862
EmailXX@XX.XX

Device Dimensions

Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge
Needle Gauge28 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885012447 [Primary]
GS120353885012441 [Package]
Contains: 00353885012447
Package: Shipper case [450 Units]
In Commercial Distribution
GS180353885012443 [Unit of Use]

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-08
Device Publish Date2021-09-30

On-Brand Devices [OneTouch Ultrasoft ]

20353885393106OneTouch Ultrasoft Lancets
20353885012441OneTouch Ultrasoft Lancets

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