CardioChek 5700412

GUDID 20304040037731

CardioChek 15Lipid/15Glucose

HENRY SCHEIN, INC.

Multiple lipid analyte IVD, kit, multiple technologies
Primary Device ID20304040037731
NIH Device Record Key9c57b087-ee22-4459-b89e-df3c69bb4ba7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioChek
Version Model Number5700412
Catalog Number5700412
Company DUNS012430880
Company NameHENRY SCHEIN, INC.
Device Count2
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040037737 [Unit of Use]
GS110304040037734 [Primary]
GS120304040037731 [Package]
Contains: 10304040037734
Package: [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBRLDL & VLDL PRECIPITATION, HDL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-12-08
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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