Easy Talk/Plus II Glucose Test Strips

GUDID 10850027494224

Box of 50 Glucose Strips compatible with Easy Talk Glucose Monitor and Easy Plus II Glucose Monitor

HOME AIDE DIAGNOSTICS, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10850027494224
• NIH Device Record Key: 7557e70f-7513-4ea4-af95-9228c5a2e1e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Talk/Plus II Glucose Test Strips
• Version Model Number: ET-PIISTR
• 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: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us
• Phone: 8009150116
• Email: info@homeaide.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027494227 [Primary]
GS1	10850027494224 [Package]; Contains: 00850027494227; Package: Box [2 Units]; In Commercial Distribution
GS1	20850027494221 [Package]; Package: Inner Carton [20 Units]; In Commercial Distribution
GS1	30850027494228 [Package]; Contains: 20850027494221; Package: Case [20 Units]; In Commercial Distribution
GS1	40850027494225 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100560

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: 2024-06-24
• Device Publish Date: 2024-06-14

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