Smartest PersonaII

GUDID 04719871820025

Smartest PersonaII Control Solution-M

BIOTEST MEDICAL CORPORATION

Home-use/point-of-care blood glucose monitoring system IVD
Primary Device ID04719871820025
NIH Device Record Keye3d40e31-ecb7-43a2-844e-0a7b64737b5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartest PersonaII
Version Model NumberGOD21
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 Usefalse
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

Phone1-888-985-1125
Emailinfo@cmihealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104719871820025 [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 Date2016-03-02

On-Brand Devices [Smartest PersonaII]

04719871820032Smartest PersonaII Glucose Meter
04719871820025Smartest PersonaII Control Solution-M
04719871820018Smartest Persona II Glucose Strip-25pcs
04719871820001Smartest PersonaII Blood Glucose Monitoring System

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