Easy Trak II Glucose Test Strips 25 count

GUDID 10850632007376

Easy Trak II Blood Glucose Test Strips for use with Easy Trak II meter only. Single use strips. 2 bottles of 25 strips in one 50 strip box.

HOME AIDE DIAGNOSTICS, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10850632007376
• NIH Device Record Key: 1154032e-dd2a-44fb-900b-7ed2c1079b21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Trak II Glucose Test Strips 25 count
• Version Model Number: 1
• Company DUNS: 783518983
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Device Count: 25
• 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: 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 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850632007379 [Primary]
GS1	10850632007376 [Package]; Contains: 00850632007379; Package: single box [2 Units]; In Commercial Distribution
GS1	20850632007373 [Package]; Package: Outer Carton [270 Units]; In Commercial Distribution
GS1	30850632007370 [Unit of Use]

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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