CardioChek 4000023

GUDID 90304040038522

CardioChek Glucose Test

HENRY SCHEIN, INC.

Glucose/ketone/lipid profile IVD, kit, multiple technologies
Primary Device ID90304040038522
NIH Device Record Key4461c5ff-53fe-4101-817a-e5919a586732
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioChek
Version Model Number4000023
Catalog Number4000023
Company DUNS012430880
Company NameHENRY SCHEIN, INC.
Device Count15
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 Perscriptiontrue
OTC Over-The-Countertrue

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040038529 [Unit of Use]
GS190304040038522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-05

On-Brand Devices [CardioChek]

00304040040539CardioChek Plus Analyzer Starter Pack
00304040037713CardioChek Plus Analyzer
90304040038522CardioChek Glucose Test
10304040037758CardioChek Capillary Tubes
10304040037741CardioChek Lipid Panel Test
20304040037731CardioChek 15Lipid/15Glucose
10304040037727Cardiochek eGLU Glucose Test

Trademark Results [CardioChek]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOCHEK
CARDIOCHEK
85939164 4455007 Live/Registered
Polymer Technology Systems, Inc.
2013-05-22
CARDIOCHEK
CARDIOCHEK
78621442 3085202 Live/Registered
Polymer Technology Systems, Inc.
2005-05-02
CARDIOCHEK
CARDIOCHEK
73201159 1141581 Dead/Cancelled
Cardiac Pacemakers, Inc.
1979-01-24

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