FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Lifelines iEEG
DI: 05694110063090
·
Model: Acquisition
·
Kvikna Medical ehf.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lifelines iEEG
- Primary DI
- 05694110063090
- Version / Model
- Acquisition
- Company Name
- Kvikna Medical ehf.
- Labeler DUNS
- 500793540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-09
- Public Version
- 6
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 0d781276-a66a-471b-8274-46971c75eb6f
- Distribution End Date
- 2021-01-15
Device Description
The Lifelines iEEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG. Acquisition systems consist of the Lifelines iEEG software, an EEG amplifier and an off the shelf computer, along with various additional options such as video cameras (1 or 2), a photic stimulator and a bag or a cart for the system.
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 Unsafe
- 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 |
|---|---|---|---|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | Neurology | 882.1400 | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38736 | Electroencephalographic monitoring system | An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features. | No | Active |
| 11467 | Electroencephalograph | An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05694110063090 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143487 | 000 |