CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) 2729

GUDID 00381932729017

CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic devices used to monitor glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus analyzer.

POLYMER TECHNOLOGY SYSTEMS, INC.

Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, enzyme spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry Multiple clinical chemistry enzyme IVD, kit, spectrophotometry

• Primary Device ID: 00381932729017
• NIH Device Record Key: fdcb6735-9a33-4208-8714-6783156507d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk)
• Version Model Number: 2729
• Catalog Number: 2729
• 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: true
• 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: 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)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
• 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
• Phone: +1(888)877-5610
• Email: customerservice@ptsdiagnostics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381932729017 [Primary]
GS1	10381932729014 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022898

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

On-Brand Devices [CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk)]

• 00381932729017: CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic devices used to
• 00381932478014: CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic devices used to