PIANO

Basic Information

• Brand Name: PIANO
• Primary DI: 08054187380235
• Version / Model: PIANO PLUS VRA
• Catalog Number: 10300
• Company Name: INVENTIS SRL
• Labeler DUNS: 338454995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 3
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 5e737e16-80d9-4e38-b1e2-a5baaa64d239

Device Description

AUDIOMETER. Piano Plus VRA is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; supra-threshold tests; High Frequency and Multi-frequency audiometry; Bekesy and MLD tests; pediatric audiometry.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
34013	Visual-reinforcement audiometer	An electroacoustic device used to evaluate the hearing of young children. Appropriate responses to test signals are rewarded by the automatic presentation of pictures that are attractive to the child.	No	Active
37503	Tone audiometer	An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08054187380235	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]