Advanced Sound Unit

Basic Information

• Brand Name: Advanced Sound Unit
• Primary DI: 04527799703678
• Version / Model: NS-S10U
• Company Name: PARAMOUNT BED CO., LTD.
• Labeler DUNS: 690552500
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-02
• Public Version: 1
• Public Version Date: 2022-01-10
• Public Version Status: New
• Public Device Record Key: 32d7e629-9c76-4da0-8e44-373148c2e928

Device Description

Electrical Hospital Bed Accessory to be used for providing notification to a patient and intended users

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	880.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36759	Loudspeaker	A transducer by which acoustic waves are produced from electrical oscillation waves and which is designed to radiate acoustic power into the surrounding medium. It can operate, e.g., by the motion of a conductor or coil, carrying a varying current, in a steady magnetic field or by electrostatic forces.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04527799703678	GS1