GL GoodLife 3K-01-16003C

GUDID 00389154000198

GL GoodLife AC-300 Blood Glucose Monitoring System

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use
Primary Device ID00389154000198
NIH Device Record Keyff15bbdf-cfaf-4b2a-9286-5165646c1fd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGL GoodLife
Version Model NumberAC11
Catalog Number3K-01-16003C
Company DUNS658644174
Company NameHMD BIOMEDICAL 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 Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100389154000198 [Primary]
GS100389154000655 [Package]
Package: [63 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

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 Date2016-08-17

On-Brand Devices [GL GoodLife ]

00389154000372GL GoodLife Blood Glucose Monitoring System(Cloudia)
00389154000198GL GoodLife AC-300 Blood Glucose Monitoring System
04711200721850The GoodLife AC-300 Professional Blood Glucose Monitoring System.(No NFC)

Trademark Results [GL GoodLife]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GL GOODLIFE
GL GOODLIFE
86640661 4966227 Live/Registered
HMD Biomedical Inc.
2015-05-26
GL GOODLIFE
GL GOODLIFE
85277770 4100217 Live/Registered
HMD BIOMEDICAL INC.
2011-03-26

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