Disposables Kit

GUDID 04961333255986

6650 Disposables Kit (MU0P00001081)(Accessory for PAS 6600)

PENTAX OF AMERICA, INC.

Speech assistive training device

• Primary Device ID: 04961333255986
• NIH Device Record Key: 63eb6374-5814-4642-b7c1-791bb7336a72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposables Kit
• Version Model Number: 6650
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333255986 [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: 2025-07-29
• Device Publish Date: 2025-07-21

Devices Manufactured by PENTAX OF AMERICA, INC.

• 04961333255696 - Digital Capture v3.7.0: 2025-09-22 9380 Digital Capture Software
• 04961333255979 - MICROPHONE ASSAY KIT: 2025-07-29 6651 MICROPHONE ASSAY KIT(MU0P00000956)(Accessory for PAS 6600)
• 04961333255986 - Disposables Kit: 2025-07-29 6650 Disposables Kit (MU0P00001081)(Accessory for PAS 6600)
• 04961333255986 - Disposables Kit: 2025-07-29 6650 Disposables Kit (MU0P00001081)(Accessory for PAS 6600)
• 04961333255016 - LARYNGOSTROBOSCOPE: 2025-05-05 LARYNGEAL STROBE 9500
• 04961333255702 - LARYNGOSTROBOSCOPE: 2025-05-05 9500LX, Laryngeal Microphone "Accessory for 9500"
• 04961333255719 - LARYNGOSTROBOSCOPE: 2025-05-05 9500MC, Lapel Microphone "Accessory for 9500"
• 04961333255726 - LARYNGOSTROBOSCOPE: 2025-05-05 9500FS, Footswitch "Accessory for 9500 "
• 00854924006255 - C2 CryoBalloon Ablation System: 2025-04-14 Gen 2 360 Degree Pear Catheter