IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips)

GUDID 00804084000143

Ideal Life Inc

Glucose monitoring system IVD, home-use
Primary Device ID00804084000143
NIH Device Record Key102cd6f9-4072-403d-ad9d-f60d29f13787
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips)
Version Model NumberAGS-1112
Company DUNS205155174
Company NameIdeal Life 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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-888-433-2541
Emailinfo@ideallife.com

Device Dimensions

Length7 Centimeter

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100804084000143 [Primary]
GS110804084000140 [Package]
Package: [50 Units]
In Commercial Distribution
GS120804084000147 [Package]
Contains: 10804084000140
Package: [160 Units]
In Commercial Distribution
GS140804084000141 [Package]
Package: [160 Units]
In Commercial Distribution

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 Number2
Public Version Date2019-08-07
Device Publish Date2019-07-22

Devices Manufactured by Ideal Life Inc

10804084000010 - IDEAL LIFE BP-Manager™2019-11-08
00804084000112 - IDEAL LIFE BP-Manager™2019-11-08 BP Manager
00804084000150 - IDEAL LIFE Control Solution Level II2019-08-08 For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions
00804084000143 - IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips)2019-08-07
00804084000143 - IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips)2019-08-07
10804084000065 - IDEAL LIFE SPO2 Manager™2019-07-17
10804084000102 - IDEAL LIFE SPO2 Manager™2019-07-17

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