Home GUDID 04961333229666 N/A
Primary DI 04961333229666
Brand N/A
Company PENTAX OF AMERICA, INC.
Model 4302
Device description Microphone, Headset Condensor Type
Published 2017-04-05
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 Product Codes# Code, Name table Code Name KLX Electroglottograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KLX Electroglottograph Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04961333229666 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04961333229666 04961333229666 4961333229666
GMDN Terms# Term, Definition table Term Definition Voice amplification system An 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.
Regulatory Flags# DUNS number 083211284 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04961333255979 MICROPHONE ASSAY KIT PENTAX OF AMERICA, INC. KLX 2025-07-21 04961333255986 Disposables Kit PENTAX OF AMERICA, INC. KLX 2025-07-21 00860011116905 Two Channel Electroglottograph EG2-PCX2 Glottal Enterprises, Inc. KLX 2024-07-01 04961333254309 MULTI-SPEECH PENTAX OF AMERICA, INC. KLX 2023-08-25 04961333247301 NASOMETER PENTAX OF AMERICA, INC. KLX 2019-06-07 04961333247318 NASOMETER PENTAX OF AMERICA, INC. KLX 2019-06-07 04961333247417 PHONATORY AERODYNAMIC SYSTEM (SOFTWARE) PENTAX OF AMERICA, INC. KLX 2019-06-07 04961333247424 PHONATORY AERODYNAMIC SYSTEM PENTAX OF AMERICA, INC. KLX 2019-06-07 04961333245390 VISI-PITCH PENTAX OF AMERICA, INC. KLX 2018-07-05 04961333245406 N/A PENTAX OF AMERICA, INC. KLX 2018-07-05 04961333245413 NASOMETER II PENTAX OF AMERICA, INC. KLX 2018-07-05 04961333245420 PHONATORY AERODYNAMIC SYSTEM PENTAX OF AMERICA, INC. KLX 2018-07-05 04961333244621 VISI-PITCH PENTAX OF AMERICA, INC. KLX 2018-03-26 04961333244638 NASOMETER II PENTAX OF AMERICA, INC. KLX 2018-03-26 04961333244645 PHONATORY AERODYNAMIC SYSTEM PENTAX OF AMERICA, INC. KLX 2018-03-26 04961333241965 N/A PENTAX OF AMERICA, INC. KLX 2018-03-06 04961333240487 N/A PENTAX OF AMERICA, INC. KLX 2018-02-26 04961333236558 NASOMETER II PENTAX OF AMERICA, INC. KLX 2017-11-14 04961333236565 PHONATORY AERODYNAMIC SYSTEM PENTAX OF AMERICA, INC. KLX 2017-11-14 04961333236572 VISI-PITCH PENTAX OF AMERICA, INC. KLX 2017-11-14 04961333236589 N/A PENTAX OF AMERICA, INC. KLX 2017-11-14 04961333236718 N/A PENTAX OF AMERICA, INC. KLX 2017-11-09 04961333235421 CAPE V PENTAX OF AMERICA, INC. KLX 2017-09-05 04961333235438 VISI-PITCH PENTAX OF AMERICA, INC. KLX 2017-09-05 04961333235445 N/A PENTAX OF AMERICA, INC. KLX 2017-09-05 04961333229864 N/A PENTAX OF AMERICA, INC. KLX 2017-04-07 04961333230020 MULTI-SPEECH PENTAX OF AMERICA, INC. KLX 2017-04-07 04961333230037 N/A PENTAX OF AMERICA, INC. KLX 2017-04-07 04961333230044 N/A PENTAX OF AMERICA, INC. KLX 2017-04-07 04961333230051 N/A PENTAX OF AMERICA, INC. KLX 2017-04-07