One Touch SureSoft

GUDID 53885-139-20

One Touch SureSoft Single Use Disposable Lancing Device

LifeScan Europe GmbH

Manual blood lancing device, single-use
Primary Device ID53885-139-20
NIH Device Record Keyb200b442-8a2a-4d2e-9ac3-562d15f65dcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne Touch SureSoft
Version Model Number021-139
Company DUNS480240820
Company NameLifeScan Europe GmbH
Device Count200
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Needle Gauge21 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885006828 [Primary]
GS120353885006822 [Package]
Contains: 00353885006828
Package: [20 Units]
In Commercial Distribution
NDC/NHRIC53885-139-20 [Secondary]
GS180353885006824 [Unit of Use]

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[53885-139-20]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [One Touch SureSoft ]

20353885006839One Touch SureSoft Single Use Disposable Lancing Device
53885-139-20One Touch SureSoft Single Use Disposable Lancing Device

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