FDA.reportPublic FDA data

N/A

Primary DI
04961333229710
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
4345
Device description
Microphone Accessory Kit
Published
2017-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KLXElectroglottograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLXElectroglottographEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333229710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333229710049613332297104961333229710

GMDN Terms#

Term, Definition table
TermDefinition
Voice amplification systemAn assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333255979 MICROPHONE ASSAY KITPENTAX OF AMERICA, INC.KLX2025-07-21
04961333255986Disposables KitPENTAX OF AMERICA, INC.KLX2025-07-21
00860011116905Two Channel Electroglottograph EG2-PCX2Glottal Enterprises, Inc.KLX2024-07-01
04961333254309MULTI-SPEECHPENTAX OF AMERICA, INC.KLX2023-08-25
04961333247301NASOMETERPENTAX OF AMERICA, INC.KLX2019-06-07
04961333247318NASOMETERPENTAX OF AMERICA, INC.KLX2019-06-07
04961333247417PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)PENTAX OF AMERICA, INC.KLX2019-06-07
04961333247424PHONATORY AERODYNAMIC SYSTEMPENTAX OF AMERICA, INC.KLX2019-06-07
04961333245390VISI-PITCHPENTAX OF AMERICA, INC.KLX2018-07-05
04961333245406N/APENTAX OF AMERICA, INC.KLX2018-07-05
04961333245413NASOMETER IIPENTAX OF AMERICA, INC.KLX2018-07-05
04961333245420PHONATORY AERODYNAMIC SYSTEMPENTAX OF AMERICA, INC.KLX2018-07-05
04961333244621VISI-PITCHPENTAX OF AMERICA, INC.KLX2018-03-26
04961333244638NASOMETER IIPENTAX OF AMERICA, INC.KLX2018-03-26
04961333244645PHONATORY AERODYNAMIC SYSTEMPENTAX OF AMERICA, INC.KLX2018-03-26
04961333241965N/APENTAX OF AMERICA, INC.KLX2018-03-06
04961333240487N/APENTAX OF AMERICA, INC.KLX2018-02-26
04961333236558NASOMETER IIPENTAX OF AMERICA, INC.KLX2017-11-14
04961333236565PHONATORY AERODYNAMIC SYSTEMPENTAX OF AMERICA, INC.KLX2017-11-14
04961333236572VISI-PITCHPENTAX OF AMERICA, INC.KLX2017-11-14
04961333236589N/APENTAX OF AMERICA, INC.KLX2017-11-14
04961333236718N/APENTAX OF AMERICA, INC.KLX2017-11-09
04961333235421CAPE VPENTAX OF AMERICA, INC.KLX2017-09-05
04961333235438VISI-PITCHPENTAX OF AMERICA, INC.KLX2017-09-05
04961333235445N/APENTAX OF AMERICA, INC.KLX2017-09-05
04961333229864N/APENTAX OF AMERICA, INC.KLX2017-04-07
04961333230020MULTI-SPEECHPENTAX OF AMERICA, INC.KLX2017-04-07
04961333230037N/APENTAX OF AMERICA, INC.KLX2017-04-07
04961333230044N/APENTAX OF AMERICA, INC.KLX2017-04-07
04961333230051N/APENTAX OF AMERICA, INC.KLX2017-04-07