Easy Plus II

GUDID 04719871820094

Easy Plus II Control Solution-Low

BIOTEST MEDICAL CORPORATION

Glucose IVD, control
Primary Device ID04719871820094
NIH Device Record Keyf60a344e-9d48-41c4-8da9-ca041889e788
Commercial Distribution Discontinuation2016-05-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEasy Plus II
Version Model NumberGOD31(BZL001HAB)
Company DUNS658447255
Company NameBIOTEST MEDICAL CORPORATION
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104719871820094 [Primary]

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 Date2018-03-29
Device Publish Date2016-05-02

On-Brand Devices [Easy Plus II]

04719871820124Easy Plus II Control Solution Kit-Low
04719871820117Easy Plus II Control Solution Kit-High
04719871820100Easy Plus II Test Strip 25x2
04719871820094Easy Plus II Control Solution-Low
04719871820087Easy Plus II Control Solution-High
04719871820070Easy Plus II Blood Glucose Test Strip
04719871820063Easy Plus II Glucose Meter, 6276-S
04719871820056Easy Plus II Blood Glucose Monitoring System 6276-S

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