FDA UDI
In Commercial Distribution
🇺🇸 United States
Polysmith Version 11.0
DI: 00817111020779
·
Model: 11.0
·
Neurotronics, LLC
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Polysmith Version 11.0
- Primary DI
- 00817111020779
- Version / Model
- 11.0
- Company Name
- Neurotronics, LLC
- Labeler DUNS
- 036405363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-10
- Public Version
- 6
- Public Version Date
- 2023-04-14
- Public Version Status
- Update
- Public Device Record Key
- 74fe27ba-8b5f-41b8-aa39-e154523585a4
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
- Yes
- 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 |
|---|---|---|---|---|
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | Neurology | 882.1400 | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | Neurology | 882.1400 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| MNR | Ventilatory Effort Recorder | Anesthesiology | 868.2375 | 2 |
| GWL | Amplifier, Physiological Signal | Neurology | 882.1835 | 2 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42238 | Sleep disorder interpretive software | An interpretive software program intended to collect and analyse patient physiological data during sleep and publish reports to assist a healthcare professional in the diagnosis of sleep disorders (e.g., insomnia, snoring, sleep apnoea) or to help evaluate treatment (e.g., positive airway pressure). It may be used as part of a complete polysomnography study using a wide range of data (e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement), or as part of a home-based study using a more limited data set [e.g., photoplethysmography (PPG) and motion tracking]. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817111020779 | GS1 |