HARP

Basic Information

• Brand Name: HARP
• Primary DI: 08054187380068
• Version / Model: HARP PLUS
• Catalog Number: 10146
• 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: 6705af43-2a6e-460a-a79a-d843224e0cdd

Device Description

AUDIOMETER. Harp Plus is an advanced diagnostic audiometer, capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; and certain supra-threshold tests.

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
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	08054187380068	GS1

Customer Contacts

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