Identity
- Trade Name
- Blom-Singer FDA UDI
- Generic Name
- Voice amplification system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- EL 2000 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009460591 FDA UDI
- FDA Product Code
- ESE FDA UDI
- GMDN Term
- Voice amplification system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Voice amplification system
Blom-Singer by Fountain Head Marketing Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fountain Head Marketing Inc
Sources (1)
- FDA UDI 364e6504-0aa5-4ad7-8987-86e767c56b63 33 fields · synced Jun 8, 2026