Fortell Charging Case

GUDID 00860014635823

Fortell Charging Case (Dark Gray)

Fortell Research Inc.

Noninvasive device battery charger

• Primary Device ID: 00860014635823
• NIH Device Record Key: 8d2fab2e-d9a2-40d6-a1d3-e333a754445e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortell Charging Case
• Version Model Number: CCUB-001-DGR
• Company DUNS: 118094664
• Company Name: Fortell Research Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014635823 [Primary]
GS1	00860014635830 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• OSM: Hearing Aid, Air-Conduction With Wireless Technology, Prescription

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: 2025-12-17
• Device Publish Date: 2025-12-09

Devices Manufactured by Fortell Research Inc.

• 00860014635823 - Fortell Charging Case: 2025-12-17Fortell Charging Case (Dark Gray)
• 00860014635823 - Fortell Charging Case: 2025-12-17 Fortell Charging Case (Dark Gray)
• 00860014635809 - Fortell AI Hearing Aid: 2025-12-10 Fortell AI Hearing Aids (Rx, Silver)