GL GoodLife 3K-01-16003G

GUDID 04711200721850

The GoodLife AC-300 Professional Blood Glucose Monitoring System.(No NFC)

HMD BIOMEDICAL INC.

Home-use/point-of-care blood glucose/blood pressure monitoring system
Primary Device ID04711200721850
NIH Device Record Keyed8bc5ec-7242-4915-89db-1bc12eb0f04b
Commercial Distribution Discontinuation2017-03-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGL GoodLife
Version Model NumberAC11-NFC
Catalog Number3K-01-16003G
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 Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-877-288-2722
EmailSales@gl-diabetes.com

Operating and Storage Conditions

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
GS104711200721850 [Primary]
GS104711200722154 [Package]
Package: [63 Units]
Not 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 Date2016-09-01

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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