Assy Vial, eGLU, 13 ct. REF 2488

GUDID 10381932488010

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: 10381932488010
• NIH Device Record Key: ac2f86ca-e9ef-41f0-9f60-7cb3d058af40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assy Vial, eGLU, 13 ct.
• Version Model Number: REF 2488
• Catalog Number: REF 2488
• Company DUNS: 835772872
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Device Count: 13
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)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 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381932488013 [Primary]
GS1	10381932488010 [Unit of Use]

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: 2023-08-07
• Device Publish Date: 2023-07-30

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