Easy Talk/PlusII Control Solution HIGH

GUDID 10850027494316

Easy Talk/PlusII Control Solution HIGH

HOME AIDE DIAGNOSTICS, INC.

Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control

• Primary Device ID: 10850027494316
• NIH Device Record Key: 9f4a8ca1-dcfe-43a9-b33c-4a60fe2322cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Talk/PlusII Control Solution HIGH
• Version Model Number: ET-PIICTR
• 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: 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	00850027494319 [Primary]
GS1	10850027494316 [Package]; Contains: 00850027494319; Package: case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100560

FDA Product Code

• LZA: Polymer Patient Examination Glove

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

Devices Manufactured by HOME AIDE DIAGNOSTICS, INC.

• 10850058864102 - True-Comfort Pen Needles 4mm: 2024-07-05 100ct box. 32G x 5/32 (4mm) Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile ne
• 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: 2024-06-24Easy Talk/PlusII Control Solution HIGH
• 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}