DEVICE: CardioChek (00304040037713)
Device Identifier (DI) Information
CardioChek
5700411
In Commercial Distribution
5700411
HENRY SCHEIN, INC.
5700411
In Commercial Distribution
5700411
HENRY SCHEIN, INC.
CardioChek Plus Analyzer
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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
[?]Size Type Text |
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No Device Sizes |
Device Record Status
70e8306b-253e-4eb0-aa8b-8f259464e279
July 06, 2018
3
January 05, 2017
July 06, 2018
3
January 05, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined