PHONATORY AERODYNAMIC SYSTEM

GUDID 04961333245420

v4.0 PAS WIN10 UPGRADE

PENTAX OF AMERICA, INC.

Electroglottograph
Primary Device ID04961333245420
NIH Device Record Key9c8e958c-b3b7-4bb2-ab7d-3db73e6f2e5c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHONATORY AERODYNAMIC SYSTEM
Version Model Number6600WU
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333245420 [Primary]

FDA Product Code

KLXElectroglottograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-06
Device Publish Date2018-07-05

On-Brand Devices [PHONATORY AERODYNAMIC SYSTEM]

04961333245420v4.0 PAS WIN10 UPGRADE
04961333244645NASOMETER II (JAPAN)
04961333236565PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
04961333231522PAS MICROPHONE
0496133323106530 ADULT LARGE DISPOSABLE MASK
0496133323105830 ADULT MED. DISPOSABLE MASKS
0496133323104130 ADULT SMALL DISPOSABLE MASK
0496133323103430 PEDIATRIC DISPOSABLE MASKS
04961333230624Phonatory Aerodynamic System for CSL, Model 4500 Users
04961333230501Flowhead Tubes, Set of 8
04961333230136Pressure Port Tubes, 25 Qty
04961333230129PAS Airflow Head-to-Mask Couplers
04961333230112PAS Tubes, Pressure Screening
04961333230105PAS Tubes, Cardboard
04961333230099PAS Pediatric Mask & Adapter (Reusable)
04961333230082PAS Mask and Adapter (Reusable)
04961333230075PAS Airflow Head
04961333229918PAS Tubes, Intraoral
04961333229901Phonatory Aerodynamic System
04961333247424PHONATORY AERODYNAMIC SYSTEM CE

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