FDA UDI
In Commercial Distribution
🇺🇸 United States
WinSlate
DI: B398WSKD0
·
Model: WinSlate for Kids
·
FORBES REHAB SERVICES INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WinSlate
- Primary DI
- B398WSKD0
- Version / Model
- WinSlate for Kids
- Company Name
- FORBES REHAB SERVICES INC
- Labeler DUNS
- 620089854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-03
- Public Version
- 1
- Public Version Date
- 2019-06-11
- Public Version Status
- New
- Public Device Record Key
- 3bbc656a-627d-4085-b3a0-0b5badd856e2
Device Description
WinSlate for Kids Speech Generating Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 | B398WSKD0 | HIBCC |
Customer Contacts
- Phone
- 4195897688
- [email protected]
- Phone
- 4195897688
- [email protected]
- Phone
- 4195897688
- [email protected]
- Phone
- 4195897688
- [email protected]