AccessGUDID - DEVICE: Blom-Singer (00860009460591)

GUDID

Device Identifier (DI) Information

Brand Name: Blom-Singer
Version or Model: EL 2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fountain Head Marketing Inc.

Primary DI Number: 00860009460591
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830442310 *Terms of Use

Device Description: ABS plastic barrel electronic larynx provides users the ability to fully customize both volume and pitch. Never replace batteries again with its permanent Lithium-Ion battery. Charging is made simple with included magnetic USB charging cable. Includes either a country-specific or universal charging block.

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?
30076	Voice amplification system	An assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ESE	Larynx, Artificial (Battery-Powered)

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: 364e6504-0aa5-4ad7-8987-86e767c56b63
Public Version Date: November 23, 2023
Public Version Number: 1
DI Record Publish Date: November 15, 2023