FDA.reportPublic FDA data

CONNEXX

Primary DI
04056839109007
Brand
CONNEXX
Company
Ws Audiology Usa, Inc.
Model
Charging Station
Catalog number
10966948
Device description
SET CHARGING STATION(EU)
Published
2024-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

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
04056839109007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056839109007040568391090074056839109007

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

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880279566SigniaPortable Charger Pure210488862026-05-27
05714880279573SigniaTravel Charger RIC RB210488872026-05-27
05714880293470SigniaPortable Charger Pure210538702026-05-27
05714880293487SigniaTravel Charger RIC RB210538712026-05-27
05714880295054SIGNIAActive Mini 7IX210540642026-05-22
05714880295061SIGNIAActive Mini 5IX210543622026-05-22
05714880295078SIGNIAActive Mini 5IX210543672026-05-22
05714880295689SIGNIAActive Mini 7IX210540692026-05-22
05714880295764SIGNIAActive Mini 3IX210543632026-05-22
05714880295771SIGNIAActive Mini 3IX210543682026-05-22
05714880295825SIGNIAActive Mini 2IX210543642026-05-22
05714880295832SIGNIAActive Mini 2IX210543692026-05-22
05714880295887SIGNIAActive Mini 1IX210543652026-05-22
05714880295894SIGNIAActive Mini 1IX210543702026-05-22
05714880295948SIGNIAActive Mini sDEMO DIX210543662026-05-22
05714880295955SIGNIAActive Mini sDEMO DIX210543712026-05-22
05714880295962SIGNIAKit Active Mini sDEMO DIX210543762026-05-22
05714880295979SIGNIAKit Active Mini 7IX210540742026-05-22
05714880296006SIGNIAKit Active Mini 5IX210543722026-05-22
05714880296037SIGNIAKit Active Mini 3IX210543732026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880279566SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880279573SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880293470SigniaWs Audiology Usa, Inc.OSM2026-05-27
05714880293487SigniaWs Audiology Usa, Inc.OSM2026-05-27
07613275596814PhonakSonova AGOSM2018-02-28
07613275596845PhonakSonova AGOSM2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601402PhonakSonova AGOSM2018-02-28
07613275601426PhonakSonova AGOSM2018-02-28
07613275601501PhonakSonova AGOSM2018-02-28
07613275601518PhonakSonova AGOSM2018-02-28
07613275601556PhonakSonova AGOSM2018-02-28
07613275601594PhonakSonova AGOSM2018-02-28
07613275601600PhonakSonova AGOSM2018-02-28
07613275601655PhonakSonova AGOSM2018-02-28
07613275601662PhonakSonova AGOSM2018-02-28
07613275601686PhonakSonova AGOSM2018-02-28
07613275601693PhonakSonova AGOSM2018-02-28
07613275602935PhonakSonova AGOSM2018-02-28
07613275602959PhonakSonova AGOSM2018-02-28