NASOMETER II

GUDID 04961333244638

COMPUTERIZED SPEECH LAB (JAPAN)

PENTAX OF AMERICA, INC.

Electroglottograph

• Primary Device ID: 04961333244638
• NIH Device Record Key: c36fda94-b567-416f-b543-d563495b9cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NASOMETER II
• Version Model Number: 4500-JP
• 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	04961333244638 [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: 2018-04-26
• Device Publish Date: 2018-03-26

On-Brand Devices [NASOMETER II]

• 04961333245413: v4.0 NASOMETER WIN10 UPGRADE
• 04961333244638: COMPUTERIZED SPEECH LAB (JAPAN)
• 04961333236558: NASOMETER II (SOFTWARE)
• 04961333229895: Nasometer