FDA.reportPublic FDA data

SIGNIA

Primary DI
05714880297577
Brand
SIGNIA
Company
Ws Audiology Usa, Inc.
Model
CHARGER BTE SP
Catalog number
21053881
Device description
SET CHARGER BTE SP USKA
Published
2026-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
05714880297577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880297577057148802975775714880297577

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.

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880288117SIGNIAD&C Charger RIC210518832026-07-16
05714880288124SIGNIAD&C Charger BTE SP210518842026-07-16
05714880288131SIGNIAD&C CHARGER BTE P210518852026-07-16
05714880288148SIGNIAD&C Charger slimRIC210518862026-07-16
05714880288155CONNEXXCharging+ Station B-HP210518882026-07-16
05714880288162CONNEXXCharging+ Station R210518872026-07-16
05714880288179CONNEXXCharging+ Station B-P210518892026-07-16
05714880288186CONNEXXCharging+ Station SR210518902026-07-16
05714880297508SIGNIACHARGER RIC210538802026-07-16
05714880297515CONNEXXCharging Station B-M210538872026-07-16
05714880297522CONNEXXCharging Station R210538862026-07-16
05714880297539CONNEXXCharging Station B-HP210538852026-07-16
05714880297546CONNEXXCharging Station B-P210538842026-07-16
05714880297553SIGNIACHARGER BTE M210538832026-07-16
05714880297560SIGNIACHARGER BTE P210538822026-07-16
05714880297928SIGNIAD&C CHARGER BTE P210558932026-07-16
05714880297935SIGNIAD&C Charger BTE SP210558942026-07-16
05714880297942SIGNIAD&C Charger RIC210558952026-07-16
05714880297959SIGNIAD&C Charger slimRIC210558962026-07-16
05714880297966CONNEXXCharging+ Station R210558972026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880288117SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288124SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288131SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288148SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880288155CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288162CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288179CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880288186CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297508SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297515CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297522CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297539CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297546CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297553SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297560SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297928SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297935SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297942SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297959SIGNIAWs Audiology Usa, Inc.OSM2026-07-16
05714880297966CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297973CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297980CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
05714880297997CONNEXXWs Audiology Usa, Inc.OSM2026-07-16
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.OSM2026-06-09
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.OSM2026-06-08