FDA UDI
In Commercial Distribution
🇺🇸 United States
Blackrock NeuroPort Biopotential Signal Processing System
DI: 00814901021459
·
Model: 7.5.2
·
BLACKROCK MICROSYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Blackrock NeuroPort Biopotential Signal Processing System
- Primary DI
- 00814901021459
- Version / Model
- 7.5.2
- Catalog Number
- RS-0049, RS-0152
- Company Name
- BLACKROCK MICROSYSTEMS, LLC
- Labeler DUNS
- 827132015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-27
- Public Version
- 1
- Public Version Date
- 2022-10-05
- Public Version Status
- New
- Public Device Record Key
- 6d4e1b31-4481-4967-8da8-70282c80037f
Device Description
NeuroPort Central Suite
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| GWL | Amplifier, Physiological Signal | Neurology | 882.1835 | 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 | 00814901021459 | GS1 |
Customer Contacts
- Phone
- 8015825533
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090957 | 000 |