In Touch Lancing Device OFG00156

GUDID 00853553005141

Box of 1 Lancet Device

LIVONGO HEALTH, INC

Manual blood lancing device, reusable
Primary Device ID00853553005141
NIH Device Record Key509cf386-d1ea-41d4-9c7d-fce070785dae
Commercial Distribution StatusIn Commercial Distribution
Brand NameIn Touch Lancing Device
Version Model NumberIn Touch
Catalog NumberOFG00156
Company DUNS829984561
Company NameLIVONGO HEALTH, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800.945.4355
Emailmembersupport@livongo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853553005141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [In Touch Lancing Device]

00853553005189Black Lancing Device
00853553005141Box of 1 Lancet Device

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