FDA.reportPublic FDA data

Fortell Charging Case

Primary DI
00860014635823
Brand
Fortell Charging Case
Company
Fortell Research Inc.
Model
CCUB-001-DGR
Device description
Fortell Charging Case (Dark Gray)
Published
2025-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014635830PackageGS11In Commercial Distribution
00860014635823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014635830008600146358308600146358300860014635830
00860014635823008600146358238600146358230860014635823

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118094664
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014635809Fortell AI Hearing AidKITPK-001-SLV2025-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880113778CONNEXXWs Audiology Usa, Inc.OSM2026-05-28
05714880214345Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219425Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219432Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219449Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219456Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219463Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219470Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219869Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219876Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219883Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219890Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219906Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219913Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219944Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219951Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880279566SigniaWs Audiology Usa, Inc.OSM2026-05-27