Assy Vial, eGLU Test Strips, 1 ct, CardioChek Plus Home 4751

GUDID 00381934751016

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

• Primary Device ID: 00381934751016
• NIH Device Record Key: 55e90c30-aa47-4bdf-a4ea-34aa5afcf3cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assy Vial, eGLU Test Strips, 1 ct, CardioChek Plus Home
• Version Model Number: 4751
• Catalog Number: 4751
• 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: 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)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381934751016 [Primary]

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: 2023-04-03
• Device Publish Date: 2023-03-25

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