GLUCOCARD® W Blood Glucose Test Strips

GUDID 20015482512051

GLUCOCARD W Blood Glucose Test Strips are for use with the GLUCOCARD W blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the palm. Alternative site testing (AST) should only be used during steady-state blood glucose conditions. The GLUCOCARD W blood glucose monitoring system is intended for self-testing outside the body (in vitro) by people with diabetes as an aid to monitor the effectiveness of diabetes control. This system is not intended for use on neonates, and it is not for the diagnosis or screening of diabetes.

ARKRAY USA, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 20015482512051
• NIH Device Record Key: 63a30c9f-7fc3-4643-8735-1dca478f85db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLUCOCARD® W Blood Glucose Test Strips
• Version Model Number: 512050
• Company DUNS: 008171162
• Company Name: ARKRAY USA, 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482512057 [Primary]
GS1	10015482512054 [Package]; Contains: 00015482512057; Package: Case Shipper [12 Units]; In Commercial Distribution
GS1	20015482512051 [Package]; Contains: 10015482512054; Package: Master Shipper [18 Units]; In Commercial Distribution
GS1	50015482512052 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170064

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: 2019-04-09
• Device Publish Date: 2019-04-01

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