CardioChek 5700415

GUDID 10304040037727

Cardiochek eGLU Glucose Test

HENRY SCHEIN, INC.

Multiple lipid analyte IVD, kit, multiple technologies

• Primary Device ID: 10304040037727
• NIH Device Record Key: cac94b7c-5427-4d10-aa0c-9b17a6593e18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioChek
• Version Model Number: 5700415
• Catalog Number: 5700415
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 50
• 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: true

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040037720 [Unit of Use]
GS1	10304040037727 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-08
• Device Publish Date: 2017-01-05

On-Brand Devices [CardioChek]

• 00304040040539: CardioChek Plus Analyzer Starter Pack
• 00304040037713: CardioChek Plus Analyzer
• 90304040038522: CardioChek Glucose Test
• 10304040037758: CardioChek Capillary Tubes
• 10304040037741: CardioChek Lipid Panel Test
• 20304040037731: CardioChek 15Lipid/15Glucose
• 10304040037727: Cardiochek eGLU Glucose Test