PHONATORY AERODYNAMIC SYSTEM

GUDID 04961333245420

v4.0 PAS WIN10 UPGRADE

PENTAX OF AMERICA, INC.

Electroglottograph

• Primary Device ID: 04961333245420
• NIH Device Record Key: 9c8e958c-b3b7-4bb2-ab7d-3db73e6f2e5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHONATORY AERODYNAMIC SYSTEM
• Version Model Number: 6600WU
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333245420 [Primary]

FDA Product Code

• KLX: Electroglottograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-06
• Device Publish Date: 2018-07-05

On-Brand Devices [PHONATORY AERODYNAMIC SYSTEM]

• 04961333245420: v4.0 PAS WIN10 UPGRADE
• 04961333244645: NASOMETER II (JAPAN)
• 04961333236565: PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
• 04961333231522: PAS MICROPHONE
• 04961333231065: 30 ADULT LARGE DISPOSABLE MASK
• 04961333231058: 30 ADULT MED. DISPOSABLE MASKS
• 04961333231041: 30 ADULT SMALL DISPOSABLE MASK
• 04961333231034: 30 PEDIATRIC DISPOSABLE MASKS
• 04961333230624: Phonatory Aerodynamic System for CSL, Model 4500 Users
• 04961333230501: Flowhead Tubes, Set of 8
• 04961333230136: Pressure Port Tubes, 25 Qty
• 04961333230129: PAS Airflow Head-to-Mask Couplers
• 04961333230112: PAS Tubes, Pressure Screening
• 04961333230105: PAS Tubes, Cardboard
• 04961333230099: PAS Pediatric Mask & Adapter (Reusable)
• 04961333230082: PAS Mask and Adapter (Reusable)
• 04961333230075: PAS Airflow Head
• 04961333229918: PAS Tubes, Intraoral
• 04961333229901: Phonatory Aerodynamic System
• 04961333247424: PHONATORY AERODYNAMIC SYSTEM CE