GLUCOCARD® Shine Blood Glucose Monitoring System

GUDID 30015482541997

Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU

ARKRAY USA, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 30015482541997
• NIH Device Record Key: d962d088-365e-44f9-85bf-448394a5b536
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLUCOCARD® Shine Blood Glucose Monitoring System
• Version Model Number: 541199
• Company DUNS: 008171162
• Company Name: ARKRAY USA, 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: false
• 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: false

Customer Support Contacts

• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Test Strips 34-86 F Meter 32-122 F
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Test Strips 34-86 F Meter 32-122 F
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	30015482541997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120351

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: 2016-09-23

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