NA
- Primary DI
- 00841983102455
- Brand
- NA
- Company
- NIHON KOHDEN AMERICA, INC.
- Model
- JE-225AK
- Catalog number
- JE-225AK
- Device description
- Flat Pack Mini 64 Channel 1-64
- Published
- 2016-09-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| OLT | Non-normalizing quantitative electroencephalograph software |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00841983102455 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00841983102455 | 00841983102455 | 841983102455 | 0841983102455 |
GMDN Terms
| Term | Definition |
|---|
| Electroencephalograph | A line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain. |
Regulatory Flags
- DUNS number
- 021063219
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00195278466662 | E-EEGX | GE Healthcare Finland Oy | OLT | 2022-07-01 |
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| 05694110068040 | Stratus EEG | Kvikna Medical ehf. | OLT | 2020-09-01 |
| 04931921009161 | Neurofax | NIHON KOHDEN CORPORATION | OLT | 2020-03-24 |
| 04931921007723 | Nihon Kohden, EEG-1200A Series Neurofax | NIHON KOHDEN CORPORATION | OLT | 2019-07-24 |
| 04931921007730 | Nihon Kohden, EEG-1200A Series Neurofax | NIHON KOHDEN CORPORATION | OLT | 2019-07-24 |
| 04931921007631 | Nihon Kohden, EEG-1200A Series Neurofax | NIHON KOHDEN CORPORATION | OLT | 2019-07-24 |
| 04931921007716 | Nihon Kohden, EEG-1200A Series Neurofax | NIHON KOHDEN CORPORATION | OLT | 2019-07-24 |
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| 00840067102688 | IOMAX Adapter | CADWELL INDUSTRIES, INC. | OLT | 2019-05-13 |
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| B485CNSINX3001 | Component Neuromonitoring System | MOBERG RESEARCH INC | OLT | 2018-06-06 |
| B485CNSINX3201 | Component Neuromonitoring System | MOBERG RESEARCH INC | OLT | 2018-06-06 |
| B485CNS3101 | Component Neuromonitoring System | MOBERG RESEARCH INC | OLT | 2017-12-21 |
| 05694110063090 | Lifelines iEEG | Kvikna Medical ehf. | OLT | 2017-11-09 |
| 04931921004357 | NA | NIHON KOHDEN CORPORATION | OLT | 2017-09-27 |
| 00840067102244 | Cadwell Disposable Goggle Foam | CADWELL INDUSTRIES, INC. | OLT | 2017-07-11 |
| 00841983104008 | Polysmith Sleep System | NIHON KOHDEN AMERICA, INC. | OLT | 2017-05-24 |
| 00841983103995 | NA | NIHON KOHDEN AMERICA, INC. | OLT | 2017-05-17 |
| 00841983103988 | Neurofax | NIHON KOHDEN AMERICA, INC. | OLT | 2017-04-26 |
| 00841983103971 | NEUROFAX | NIHON KOHDEN AMERICA, INC. | OLT | 2016-11-18 |
| 05694110063052 | Lifelines iEEG Client Software | Kvikna Medical ehf. | OLT | 2016-10-03 |