FDA UDI
In Commercial Distribution
🇺🇸 United States
Accent 1400 Keyguard 45 Location
DI: 00858526006170
·
Model: 17342-45
·
PRENTKE ROMICH COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accent 1400 Keyguard 45 Location
- Primary DI
- 00858526006170
- Version / Model
- 17342-45
- Company Name
- PRENTKE ROMICH COMPANY
- Labeler DUNS
- 080143399
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- a73cced8-baae-4789-8b10-4ee23c9a3708
Device Description
The keyguard allows the Accent 1400 to be set up for specific locations to accommodate a wide range of cognitive and motor skills. Using the keyguard with the 1400 requires the device frame that came with the 1400. If a replacement frame is needed please go to 1400 Device Frame.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ILQ | System, Communication, Powered | Physical Medicine | 890.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17187 | Voice synthesizer/digitizer | An assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858526006170 | GS1 |
Customer Contacts
- Phone
- 800-262-1984
- [email protected]