GL GoodLife AC300 Test Strip-Vial 3S-01-16003C

GUDID 00389154000587

GL GoodLife AC300 Blood Glucose Test Strip

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, point-of-care
Primary Device ID00389154000587
NIH Device Record Keya289a2b6-7da4-435f-a929-f5645822b4c1
Commercial Distribution Discontinuation2018-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGL GoodLife AC300 Test Strip-Vial
Version Model NumberAC-11 vial
Catalog Number3S-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 Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100389154000570 [Primary]
GS100389154000587 [Package]
Contains: 00389154000570
Package: [400 Units]
Discontinued: 2018-12-31
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 Number5
Public Version Date2019-08-09
Device Publish Date2016-11-17

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