Primary Device ID | 00381931757011 |
NIH Device Record Key | e51c70a5-7dc6-4db4-8f63-1a2be63f8758 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CardioChek® PA Professional Analyzer, Refurbished |
Version Model Number | 1757 |
Catalog Number | 1757 |
Company DUNS | 835772872 |
Company Name | POLYMER TECHNOLOGY SYSTEMS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | true |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00381931757011 [Primary] |
JGY | COLORIMETRIC METHOD, TRIGLYCERIDES |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-07-15 |
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10381934747016 - Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home | 2023-04-03 CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL |
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Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARDIOCHEK 85939164 4455007 Live/Registered |
Polymer Technology Systems, Inc. 2013-05-22 |
CARDIOCHEK 78621442 3085202 Live/Registered |
Polymer Technology Systems, Inc. 2005-05-02 |
CARDIOCHEK 73201159 1141581 Dead/Cancelled |
Cardiac Pacemakers, Inc. 1979-01-24 |