AccessGUDID - DEVICE: TIMPANI DOCKING STATION (08054187380761)

GUDID

Device Identifier (DI) Information

Brand Name: TIMPANI DOCKING STATION
Version or Model: TIMPANI DOCKING STATION
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11508
Company Name: INVENTIS SRL

Primary DI Number: 08054187380761
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338454995 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PTO	Tester, Auditory Impedance, Exempt
EWO	Audiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 945fb3af-6d2f-4f9d-90d7-0c1f116c68ce
Public Version Date: August 03, 2023
Public Version Number: 2
DI Record Publish Date: January 04, 2023