FDA UDI
In Commercial Distribution
🇺🇸 United States
Audioscan
DI: B161RM500SL0
·
Model: RM500SL
·
Etymonic Design Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Audioscan
- Primary DI
- B161RM500SL0
- Version / Model
- RM500SL
- Company Name
- Etymonic Design Incorporated
- Labeler DUNS
- 244780581
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 7a544816-4d15-4362-895f-1fdc220f0af5
Device Description
The RM500SL is a portable hearing aid analyzer intended to be used by hearing care professionals such as audiologists and hearing aid specialists to verify the electro-acoustic performance of a hearing aid connected to a standard earphone coupler or while worn on the ear of the end user.
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | Ear, Nose, Throat | 874.3310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45241 | Audiometric/hearing aid tester | An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B161RM500SL3 | HIBCC | Carton | 1 | In Commercial Distribution | |
| Primary | B161RM500SL0 | HIBCC |
Customer Contacts
- Phone
- 15192683313
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 50 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 81 – 106 KiloPascal