AccessGUDID - DEVICE: Jacoti Hearing Center (05407004250021)

GUDID

Device Identifier (DI) Information

Brand Name: Jacoti Hearing Center
Version or Model: Jacoti Hearing Center 1.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jacoti

Primary DI Number: 05407004250021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 762560282 *Terms of Use

Device Description: Jacoti Hearing Center 1.X

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):	No
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?
46964	Self-testing tone audiometer	A battery-powered electroacoustic device that is designed for self-testing by the user to qualitatively evaluate hearing acuity by presenting a series of tones at a fixed level. It is placed over the user's ear and a microprocessor [central processing unit (CPU)] in the device automatically produces a range of tones at pre-set decibel (dB) levels. If the user cannot hear all of the tones then this may be an indication of diminished hearing acuity and the need for formal audiological assessment. This device is available [non-prescription] over-the-counter (OTC) and is typically used in the home or a general practitioner's office.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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: 0b72a976-8db3-4f81-a228-1dbf2abecb31
Public Version Date: January 17, 2023
Public Version Number: 1
DI Record Publish Date: January 09, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +9999999999
Email: info@jacoti.com

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