Easy Trak II Control Solution High

GUDID 10850632007383

Easy Trak II Control Solution High for use with Easy Trak II strips in the Easy Trak II meter. For use only within 90 days of opening. Do not use after expiration date.

HOME AIDE DIAGNOSTICS, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10850632007383
• NIH Device Record Key: cc7affec-b084-432a-b29d-b7a5201cc34b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Trak II Control Solution High
• Version Model Number: 1
• Company DUNS: 783518983
• Company Name: HOME AIDE DIAGNOSTICS, 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: true
• 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: 1-800-915-0116
• Email: info@homeaide.us

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850632007386 [Primary]
GS1	10850632007383 [Package]; Contains: 00850632007386; Package: Outer Carton [750 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052208

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2020-01-20
• Device Publish Date: 2020-01-10

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