Romet
Basic Information
- Brand Name
- Romet
- Primary DI
- 00860009460539
- Version / Model
- R700
- Company Name
- Fountain Head Marketing Inc.
- Labeler DUNS
- 830442310
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-15
- Public Version
- 1
- Public Version Date
- 2023-11-23
- Public Version Status
- New
- Public Device Record Key
- 6a2e1d8b-967c-4e23-882f-d215b0f601ff
Device Description
Get up to date with the latest electronic larynx device, the R700! The R700 is the latest and modern electronic larynx model to hit the market. Being the most economical option out there, this artificial larynx is designed for the voice impaired adult providing countless benefits and modern improvements over other artificial larynx devices, including: Volume and pitch controls to customize the sound just the way you want it. Permanently installed Li-Ion battery saving you money on AA or AAA batteries. Gun metal electroplated Aluminum Barrel Installed Li-Ion battery offers a safer alternative to NiMH batteries. (NiMH depletes charge even when not in use) 30 hours of reliable speaking time. USB rechargeable. No batteries needed! EU adapter, USB charging cable, charging brick, and lanyard is included! Operating instructions, basic use, programming, battery information and more can be found in the Operating Instructions included with each box.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ESE | Larynx, Artificial (Battery-Powered) | Ear, Nose, Throat | 874.3375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009460539 | GS1 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 32 Degrees Celsius