FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Persyst Mobile App
DI: 00869732000142
·
Model: App for Web
·
Persyst Development Corp
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Persyst Mobile App
- Primary DI
- 00869732000142
- Version / Model
- App for Web
- Company Name
- Persyst Development Corp
- Labeler DUNS
- 159514244
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-08
- Public Version
- 3
- Public Version Date
- 2023-07-14
- Public Version Status
- Update
- Public Device Record Key
- 47d51dff-a409-4e89-997f-936ad663a803
- Distribution End Date
- 2023-07-13
Device Description
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | Neurology | 882.1400 | 2 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | Neurology | 882.1400 | 2 |
| OMA | Amplitude-Integrated Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47541 | Bioelectrical signal analysis software | A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00869732000142 | GS1 |
Customer Contacts
- Phone
- 19287080705
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171184 | 000 |