NASOMETER

GUDID 04961333247301

NASOMETER SOFTWARE

PENTAX OF AMERICA, INC.

Speech assistive training device

• Primary Device ID: 04961333247301
• NIH Device Record Key: e0b267d3-8db6-4790-99a1-4c8ec2af7434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NASOMETER
• Version Model Number: 6500
• 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	04961333247301 [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: 2019-06-17
• Device Publish Date: 2019-06-07

On-Brand Devices [NASOMETER]

• 04961333247318: NASOMETER
• 04961333247301: NASOMETER SOFTWARE