eGLU, 15ct., CCPlus Home REF 4755

GUDID 10381934755011

The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.

POLYMER TECHNOLOGY SYSTEMS, INC.

Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies

• Primary Device ID: 10381934755011
• NIH Device Record Key: 5d546f0c-4555-44a4-88d7-e4026ad228cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eGLU, 15ct., CCPlus Home
• Version Model Number: REF 4755
• Catalog Number: REF 4755
• Company DUNS: 835772872
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Device Count: 15
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)870-5610
• Email: customerservice@ptsdiagnostics.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381934755014 [Primary]
GS1	10381934755011 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140068

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by POLYMER TECHNOLOGY SYSTEMS, INC.

• 10381933080015 - A1CNow Self Check, 8ct.: 2023-11-02 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev
• 10021292015029 - TRUE+ A1CNow Self Check: 2023-08-07 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev
• 10381932488010 - Assy Vial, eGLU, 13 ct.: 2023-08-07 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who
• 10381934753017 - Lipid Panel, 15ct., CCPlus Home: 2023-06-28 CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL
• 10381934755011 - eGLU, 15ct., CCPlus Home: 2023-06-28The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
• 10381934755011 - eGLU, 15ct., CCPlus Home: 2023-06-28 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who
• 10381934752010 - Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk): 2023-06-09 CardioChek Plus Lipid + eGLU Smart Bundle™ Self-Test test strips are in vitro diagnostic devices used to measure total cholest
• 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
• 10381934748013 - Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus Home: 2023-04-03 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who