GL GoodLife Glucose Control Solution(Level 1) 3C-01-810032

GUDID 00389154000716

GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glucose System

HMD BIOMEDICAL INC.

Glucose IVD, control
Primary Device ID00389154000716
NIH Device Record Keydff656fb-df0c-4680-947c-bbec3b07d429
Commercial Distribution Discontinuation2018-12-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGL GoodLife Glucose Control Solution(Level 1)
Version Model NumberGL GCS
Catalog Number3C-01-810032
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 Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-855-692-3511
EmailSales@gl-daibetes.com
Phone1-855-692-3511
EmailSales@gl-daibetes.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100389154000440 [Primary]
GS100389154000716 [Package]
Contains: 00389154000440
Package: box [650 Units]
Discontinued: 2018-12-28
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-28
Device Publish Date2017-10-30

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