Easy Trak II Blood Glucose Meter

GUDID 10850632007369

Blood Glucose Monitor for use with Easy Trak II Testing Strips only

HOME AIDE DIAGNOSTICS, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10850632007369
• NIH Device Record Key: b9546ec6-952e-4f51-92d3-395f2dc7e913
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Trak II Blood Glucose Meter
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850632007362 [Primary]
GS1	10850632007369 [Package]; Contains: 00850632007362; Package: Outer Carton [80 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

Devices Manufactured by HOME AIDE DIAGNOSTICS, INC.

• 10850027494224 - Easy Talk/Plus II Glucose Test Strips: 2024-06-24 Box of 50 Glucose Strips compatible with Easy Talk Glucose Monitor and Easy Plus II Glucose Monitor
• 10850027494309 - Easy Talk/PlusII Control Solution LOW: 2024-06-24 Easy Talk/PlusII Control Solution LOW
• 10850027494316 - Easy Talk/PlusII Control Solution HIGH: 2024-06-24 Easy Talk/PlusII Control Solution HIGH
• 10850027494330 - True Comfort Back Compression Wrap: 2024-06-24 True Comfort Back Compression Wrap
• 10850027494613 - Easy Comfort 1L Sharps Container {1.06 Quarts}: 2024-06-24 1L Sharps Container {1.06 Quarts}
• 10850058864089 - Easy Comfort 3L Sharps Container {3.17 Quarts}: 2024-06-24 3L Sharps Container {3.17 Quarts}
• 10850058864096 - Easy Comfort 5L Sharps Container {5.28 Quarts}: 2024-06-24 5L Sharps Container {5.28 Quarts}
• 10850632007888 - Easy Comfort 0.2L Sharps Container {0.21 Quarts}: 2024-06-24 0.2L Sharps Container {0.21 Quarts}