Livongo Replacement Device KIT00423

GUDID 00853553005240

Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish)

LIVONGO HEALTH, INC

Home-use/point-of-care glucose analyser IVD, battery-powered
Primary Device ID00853553005240
NIH Device Record Key6f56fcc3-1cdf-4c30-bd35-fe7455ba6e98
Commercial Distribution StatusIn Commercial Distribution
Brand NameLivongo Replacement Device
Version Model NumberLivongo
Catalog NumberKIT00423
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 Numbertrue
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

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 0 KiloPascal and 75 KiloPascal
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 75 KiloPascal
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 75 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100853553005240 [Primary]

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

On-Brand Devices [Livongo Replacement Device]

00853553005417Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide
00853553005301BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish)
00853553005240Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide

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