FDA.reportPublic FDA data

Philips

Primary DI
05714464002849
Brand
Philips
Company
Sbo Hearing A/S
Model
204550
Device description
HEARSUITE 2019.2
Published
2019-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, tinnitus
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714464002849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714464002849057144640028495714464002849

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100eand@demant.com

Regulatory Flags#

DUNS number
306018410
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714464175659Maico2860902026-04-10
05714464175666Maico2860912026-04-10
05714464175673Maico2860922026-04-10
05714464175680Maico2860932026-04-10
05714464175697Maico2860942026-04-10
05714464175703Oticon2860952026-04-10
05714464175710Oticon2860962026-04-10
05714464175727Oticon2860972026-04-10
05714464175734Oticon2860982026-04-10
05714464175741Oticon2860992026-04-10
05714464175857Oticon2861102026-04-10
05714464175864Oticon2861112026-04-10
05714464175871Oticon2861122026-04-10
05714464175888Oticon2861132026-04-10
05714464175895Oticon2861142026-04-10
05714464175963Oticon2861212026-04-10
05714464176175Bernafon2861422026-04-10
05714464176182Bernafon2861432026-04-10
05714464176199Bernafon2861442026-04-10
05714464176205Bernafon2861452026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613275596814PhonakSonova AGOSM2018-02-28
07613275596821PhonakSonova AGKLW2018-02-28
07613275596838PhonakSonova AGKLW2018-02-28
07613275596845PhonakSonova AGOSM2018-02-28
07613275596852PhonakSonova AGKLW2018-02-28
07613275596869PhonakSonova AGOSM2018-02-28
07613275596876PhonakSonova AGKLW2018-02-28
07613275596883PhonakSonova AGOSM2018-02-28
07613275596890PhonakSonova AGKLW2018-02-28
07613275596906PhonakSonova AGKLW2018-02-28
07613275596913PhonakSonova AGKLW2018-02-28
07613275596920PhonakSonova AGKLW2018-02-28
07613275596937PhonakSonova AGKLW2018-02-28
07613275596944PhonakSonova AGOSM2018-02-28
07613275596951PhonakSonova AGOSM2018-02-28
07613275596968PhonakSonova AGOSM2018-02-28
07613275596975PhonakSonova AGKLW2018-02-28
07613275596982PhonakSonova AGOSM2018-02-28
07613275596999PhonakSonova AGOSM2018-02-28
07613275597002PhonakSonova AGOSM2018-02-28
07613275597019PhonakSonova AGOSM2018-02-28
07613275597026PhonakSonova AGKLW2018-02-28
07613275597033PhonakSonova AGOSM2018-02-28
07613275601310PhonakSonova AGKLW2018-02-28
07613275601327PhonakSonova AGOSM2018-02-28
07613275601334PhonakSonova AGKLW2018-02-28
07613275601341PhonakSonova AGKLW2018-02-28
07613275601358PhonakSonova AGKLW2018-02-28
07613275601365PhonakSonova AGKLW2018-02-28
07613275601372PhonakSonova AGKLW2018-02-28