FDA.reportPublic FDA data

Blom-Singer

Primary DI
10850057368007
Brand
Blom-Singer
Company
Ent Solutions LLC
Model
EL 1000
Device description
Electrolarynx
Published
2023-12-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ESELarynx, Artificial (Battery-Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESELarynx, Artificial (Battery-Powered)Ear, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850057368004PackageGS110In Commercial Distribution
10850057368007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085005736800420850057368004
1085005736800710850057368007

GMDN Terms#

Term, Definition table
TermDefinition
Transcervical artificial larynxA battery-powered, speech-assistive device designed to be used by a person who has had their larynx removed (laryngectomy) to assist them in the reproduction of sounds similar to those produced by the vocal cords in normal speech. It is an externally-applied electromechanical device (also known as a neck-type artificial larynx) with a plastic or metal probe that generates a sound (i.e., tone); when the probe is held against the tissues of the neck (or cheek) the tone is transmitted to the mouth through the oropharynx. The appropriate movement of the lips, tongue, teeth, and jaw converts the tone into meaningful speech (i.e., modulates the tone).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125823980
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850057368014Blom-SingerEL 10012023-12-18
10850057368021Blom-SingerEL 10022023-12-18
10850057368038Blom-SingerEL 10042023-12-18
20850057368011Blom-SingerEL 10012023-12-18
20850057368028Blom-SingerEL 10022023-12-18
20850057368035Blom-SingerEL 10042023-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850057368014Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368021Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368038Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368011Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368028Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368035Blom-SingerEnt Solutions LLCESE2023-12-18
00860009460508RometFountain Head Marketing Inc.ESE2023-11-15
00860009460515RometFountain Head Marketing Inc.ESE2023-11-15
00860009460522RometFountain Head Marketing Inc.ESE2023-11-15
00860009460539RometFountain Head Marketing Inc.ESE2023-11-15
00860009460546RometFountain Head Marketing Inc.ESE2023-11-15
00860009460591Blom-SingerFountain Head Marketing Inc.ESE2023-11-15
07331791015571Provox TruTone PlusAtos Medical ABESE2022-07-08
07331791015823Provox SolaTone PlusAtos Medical ABESE2022-07-08
07331791015830Provox TruTone EmoteAtos Medical ABESE2022-07-08
04040823006502SERVOX digital XLServona GmbHESE2021-02-18
00813124010981TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2021-02-05
00813124010738TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2020-08-24
00813124010974TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2020-08-24
00813124010868TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESESE2020-03-17
00813124010875TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESESE2020-03-17
00813124010004TruTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010035SolaTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010097TruTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010103SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010110SolaTone Lite® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010127SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010134TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010141TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010158TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23