FDA.report

Siemens

Primary DI
04046355618121
Brand
Siemens
Company
SIVANTOS, INC.
Model
HA CARAT A 5BX SLV
Catalog number
10826616
Device description
Siemens HA CARAT A 5BX SLV Hearing Aid
Published
2016-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046355618121PrimaryGS10

GMDN Terms

TermDefinition
Air-conduction hearing aid, behind-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods

Method

Contacts

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

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05714880192490SIGNIA INSIO CHARGER210251452022-11-30
05714880192506CONNEXXCUSTOM CHARGER STATION210251462022-11-30
05714880182743SonyCRE-C10210222962022-09-12
05714880148664SigniaINSIO 3AX C&G210111442022-08-30
05714880148671SigniaINSIO 5AX C&G210111452022-08-30
05714880148688SigniaINSIO 7AX C&G210111462022-08-30
05714880175882SigniaINSIO 1AX C&G210111422022-08-30
05714880175899SigniaINSIO 2AX C&G210111432022-08-30
05714880111224SigniaACC. SET STREAMLINE TV US109448242020-10-02
04025515213611SiemensHA PHOENIX 213 BG071670962016-05-05
04025515213758SiemensHA INFINITI PRO S BG087715732016-05-05
04025515218456SiemensHA INTUIS S DIR BG101720292016-05-05
04025515218463SiemensHA INTUIS S DIR GNT101720532016-05-05
04025515218470SiemensHA INTUIS S DIR BLK101720552016-05-05
04025515218487SiemensHA INTUIS DIR BG101474172016-05-05
04025515218494SiemensHA INTUIS DIR GNT101721712016-05-05
04025515218500SiemensHA INTUIS DIR BLK101721732016-05-05
04025515218517SiemensHA INTUIS SP DIR BG101473852016-05-02
04025515218524SiemensHA INTUIS SP DIR GNT101720632016-05-02
04025515218531SiemensHA INTUIS SP DIR BLK101720652016-05-02

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