In Touch Refill Kit KIT00147

GUDID 00853553005103

6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution

LIVONGO HEALTH, INC

Blood lancing device tip
Primary Device ID00853553005103
NIH Device Record Key2a519b60-696d-4dcf-87e3-68baa903f3ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameIn Touch Refill Kit
Version Model NumberIn Touch
Catalog NumberKIT00147
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 Kittrue
Device Combination Productfalse
Single Usefalse
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

Phone800.945.4355
Emailmembersupport@livongo.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100853553005103 [Primary]

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by LIVONGO HEALTH, INC

00810079260003 - Teladoc Health, Inc2023-09-04 WM1500, Modem Module FCC ID: XMR201707BG96
00810079260027 - Teladoc Health, Inc2023-09-04 SCALE, 4G CELLULAR WEIGHT MANAGEMENT, BRIDGE BRANDED, WM1500
00810079260058 - Teladoc Health, Inc2023-09-04 WM1500 Scale, BG95-M2
00853553005646 - Teladoc Health, Inc2023-09-04 KIT, WELCOME, 4G CELLULAR BODY SCALE WM1500 1 Scale, 1 Scale User Guide, 4 AA Alkaline Batteries
00853553005738 - Livongo Test Strips - Mexico2022-09-28 OFG Livongo Test Strips BG300C - Mexico. 1 Vial of 50 Test Strips.
00853553005752 - Livongo WM1500 Welcome Kit2022-05-02 1 Weight Scale, 1 Scale User Guide, 4 AA Alkaline Batteries
00853553005042 - Livongo Blood Pressure Monitor2022-04-13 HT900 Device, Cellular Blood Pressure Monitor (4G)
00853553005073 - Livongo HT900 Welcome Kit2022-04-13 1 Livongo Blood Pressure Monitor HT900, 1 Livongo Blood Pressure Cuff, 1 Travel Case, 1 User Guide, 1 Quick Start Guide, 4 Durac

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