AccessGUDID - DEVICE: CardioChek (00304040037713)

GUDID

Device Identifier (DI) Information

Brand Name: CardioChek
Version or Model: 5700411
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5700411
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040037713
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: CardioChek Plus Analyzer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered	A portable, battery-powered instrument intended to be used by health professionals at the point-of-care to analyse a clinical specimen for the qualitative and/or quantitative determination of multiple clinical chemistry analytes simultaneously from multiple analytical processes. Analytes measured may include electrolytes, specific proteins, lipids, and kidney, liver and/or cardiac function test analytes using two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.

GMDN Preferred Term Name

GMDN Definition

Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered

A portable, battery-powered instrument intended to be used by health professionals at the point-of-care to analyse a clinical specimen for the qualitative and/or quantitative determination of multiple clinical chemistry analytes simultaneously from multiple analytical processes. Analytes measured may include electrolytes, specific proteins, lipids, and kidney, liver and/or cardiac function test analytes using two or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.

FDA Product Code

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Product Code	Product Code Name
CHH	ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
JGY	COLORIMETRIC METHOD, TRIGLYCERIDES
LBR	LDL & VLDL PRECIPITATION, HDL
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
CGA	GLUCOSE OXIDASE, GLUCOSE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140068	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep away from sunlight.
Special Storage Condition, Specify: Keep dry.
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 70e8306b-253e-4eb0-aa8b-8f259464e279
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 05, 2017