Home GUDID 04961333240487 N/A
Primary DI 04961333240487
Brand N/A
Company PENTAX OF AMERICA, INC.
Model 6454
Device description 6450 CARRYING CASE
Published 2018-02-26
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 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 04961333240487 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04961333240487 04961333240487 4961333240487
GMDN Terms# Term, Definition table Term Definition Medical capital equipment storage bag/case A non-sterile, portable, protective container intended to be used by a healthcare provider to store/transport a piece of medical capital equipment (not included) between uses, and may in addition be intended to hold some device components during use; it is not intended to be worn by a patient to hold a personal medical device. It is a durable bag or case with a padded interior intended to prevent damage to medical devices. It is often designed to contain a specific type of device, however it does not include specific parent-device-supportive medical accessories, and is not intended to shield radiation. This is a reusable device.
Regulatory Flags# DUNS number 083211284 Device count 1 Premarket exempt true Lot or batch true 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 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 04961333230068 N/A PENTAX OF AMERICA, INC. KLX 2017-04-07