GL GoodLife Blood Glucose Test Strip-Foil For Cloudia 3L-10-810037

GUDID 00389154000495

GL GoodLife Blood Glucose Test Strip-Foil For Cloudia

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use
Primary Device ID00389154000495
NIH Device Record Key7c0da9e8-c47a-47dc-b3fd-18529a3f26e4
Commercial Distribution Discontinuation2018-12-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGL GoodLife Blood Glucose Test Strip-Foil For Cloudia
Version Model NumberIG STRIP FOIL
Catalog Number3L-10-810037
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
GS100389154000266 [Primary]
GS100389154000495 [Package]
Contains: 00389154000266
Package: Foil [210 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 Date2017-11-14

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