Amplivox

Basic Information

• Brand Name: Amplivox
• Primary DI: 05060488901157
• Version / Model: PC850
• Company Name: AMPLIVOX LIMITED
• Labeler DUNS: 226599157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-22
• Public Version: 1
• Public Version Date: 2024-01-01
• Public Version Status: New
• Public Device Record Key: 15b54a67-054b-4667-949b-1f72c00cc5ad

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: No
• Has Manufacturing Date: No
• 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
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63545	Vestibulo-auditory analysis system	An assembly of devices designed to assess the function of the auditory and vestibular systems using multiple vestibulo-auditory parameters which include audiometry (e.g., air, bone, speech), tympanometry, auditory evoked-potential (AEP) [e.g., auditory brainstem response (ABR)], otoacoustic emission (OAE), auditory steady-state response (ASSR), and vestibular evoked myogenic potential (VEMP). It includes a console which may be connected to an off-the-shelf computer, devices used for the transmission of stimuli and reception of electrical signals generated by the patient (e.g., preamplifier, audiometric ear tips, electrodes), and dedicated software. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060488901157	GS1