Blom-Singer

GUDID 00860009460591

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.

Fountain Head Marketing Inc.

Voice amplification system

• Primary Device ID: 00860009460591
• NIH Device Record Key: 364e6504-0aa5-4ad7-8987-86e767c56b63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blom-Singer
• Version Model Number: EL 2000
• Company DUNS: 830442310
• Company Name: Fountain Head Marketing Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009460591 [Primary]

FDA Product Code

• ESE: Larynx, Artificial (Battery-Powered)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-23
• Device Publish Date: 2023-11-15

Devices Manufactured by Fountain Head Marketing Inc.

• 00860009460508 - Romet: 2023-11-23 Experience the power of communication with the Romet R120 Electronic Larynx, a cutting-edge device designed to empower laryngect
• 00860009460515 - Romet: 2023-11-23 After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the con
• 00860009460522 - Romet: 2023-11-23 After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the con
• 00860009460539 - Romet: 2023-11-23 Get up to date with the latest electronic larynx device, the R700! The R700 is the latest and modern electronic larynx model to
• 00860009460546 - Romet: 2023-11-23 The R600 is the latest and modern electronic larynx model to hit the market. Being the most economical option out there, this ar
• 00860009460591 - Blom-Singer: 2023-11-23ABS 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.
• 00860009460591 - Blom-Singer: 2023-11-23 ABS plastic barrel electronic larynx provides users the ability to fully customize both volume and pitch. Never replace batteri