TIMPANI DOCKING STATION

Basic Information

• Brand Name: TIMPANI DOCKING STATION
• Primary DI: 08054187380761
• Version / Model: TIMPANI DOCKING STATION
• Catalog Number: 11508
• Company Name: INVENTIS SRL
• Labeler DUNS: 338454995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-04
• Public Version: 2
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 945fb3af-6d2f-4f9d-90d7-0c1f116c68ce

Device Description

TIMPANI DOCKING STATION, ACCESSORY OF TIMPANI Timpani Docking Station is an accessory of Timpani and allows the user to store away the Timpani after use, recharging the device and transferring the data to the computer.

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
PTO	Tester, Auditory Impedance, Exempt	Ear, Nose, Throat	874.1090	2
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36717	Impedance audiometer	An electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.	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	08054187380761	GS1

Customer Contacts

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