FDA UDI
In Commercial Distribution
🇺🇸 United States
Visual System Power Supply
DI: 07090042052092
·
Model: VPS-1.1
·
Nordicneurolab AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Visual System Power Supply
- Primary DI
- 07090042052092
- Version / Model
- VPS-1.1
- Company Name
- Nordicneurolab AS
- Labeler DUNS
- 671280238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-01
- Public Version
- 2
- Public Version Date
- 2020-06-02
- Public Version Status
- Update
- Public Device Record Key
- 7f5c0151-0f8f-47a0-b472-4c802d307ddb
Device Description
Visual System Power Supply (VPS) for NordicNeuroLab's Visual System HD Shielded enclosure containing the Power Supply Unit for the Visual System HD which is located in the MR environment. VPS is part of NordicNeuroLab’s VisualSystem HD. The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays.
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35373 | Visual stimulator | An electronic device used to apply visual stimuli (e.g., shifting patterns of light) to a patient's eyes. This device typically presents light to the eye through an optical system (optical stimulator), or light is viewed directly from an illuminated screen (direct-view stimulator), or light-emitting diode (LED) stimulating goggles. It is typically used as a component of several other devices such as refractors, scanning ophthalmoscopes, visual evoked potential (VEP) recording systems, or an electroretinograph (ERG). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07090042052092 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191032 | 000 |