FDA UDI
In Commercial Distribution
🇺🇸 United States
CNS Envision
DI: B485CNSENV1000
·
Model: 1.03.00
·
NATUS NEUROLOGY INCORPORATED
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CNS Envision
- Primary DI
- B485CNSENV1000
- Version / Model
- 1.03.00
- Company Name
- NATUS NEUROLOGY INCORPORATED
- Labeler DUNS
- 874257488
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-18
- Public Version
- 1
- Public Version Date
- 2023-08-28
- Public Version Status
- New
- Public Device Record Key
- 56eb7828-af02-4618-ab72-729330a1918b
Device Description
Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ORT | Burst Suppression Detection Software For Electroencephalograph | Neurology | 882.1400 | 2 |
| OMA | Amplitude-Integrated Electroencephalograph | Neurology | 882.1400 | 2 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 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 | B485CNSENV1000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192572 | 000 |