Livongo Blood Glucose Meter FG00688

GUDID 00853553005288

Livongo BG300 Blood Glucose Meter

LIVONGO HEALTH, INC

Glucose analyser IVD, home-use/point-of-care, line-powered
Primary Device ID00853553005288
NIH Device Record Key9501f300-b7dd-424a-b3d3-198ba96f6edf
Commercial Distribution StatusIn Commercial Distribution
Brand NameLivongo Blood Glucose Meter
Version Model NumberBG300
Catalog NumberFG00688
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

Handling Environment Atmospheric PressureBetween 0 KiloPascal and 75 KiloPascal
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 75 KiloPascal
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 75 KiloPascal
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 75 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100853553005288 [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 Date2017-04-07

On-Brand Devices [Livongo Blood Glucose Meter]

00853553005349Blood Glucose Meter
00853553005288Livongo BG300 Blood Glucose Meter
00853553005196Livongo BG300 Blood Glucose Meter
00853553005011BG300 rev C Blood Glucose Meter, Kaifa DongGuan

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.