MULTI-SPEECH

GUDID 04961333254309

Multi-Speech Microphone, Condensor

PENTAX OF AMERICA, INC.

Voice amplification system Voice amplification system

• Primary Device ID: 04961333254309
• NIH Device Record Key: d035b4fc-4223-4ba5-9c76-4cc020b6a8f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTI-SPEECH
• Version Model Number: 3706-1
• 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	04961333254309 [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: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [MULTI-SPEECH]

• 04961333230020: Multi-Speech USB Sound Recorder & Preamp
• 04961333230013: Multi-Speech Microphone, Dynamic
• 04961333230006: Multi-Speech Microphone, Condensor
• 04961333229659: Multi-Speech Microphone Preamp
• 04961333229642: Multi-Speech Software
• 04961333254309: Multi-Speech Microphone, Condensor