NA
- Primary DI
- 00841983100857
- Brand
- NA
- Company
- NIHON KOHDEN AMERICA, INC.
- Model
- KC-001A
- Catalog number
- KC-001A
- Device description
- STAND,INPUT BOX/PHOTIC EEG-1200
- Published
- 2016-09-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|
| 00841983100857 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00841983100857 | 00841983100857 | 841983100857 | 0841983100857 |
GMDN Terms
| Term | Definition |
|---|
| Instrument trolley | A cart used to transport medical and surgical instruments, and sometimes sterile supplies, from a central supply station or sterilization department to appropriate areas of the hospital [e.g., the operating room (OR)]. In sterilizing departments the trolley may be used in the sterilizing process, and for sterilized instruments the cart may be designed to accommodate sterile wraps/packaging and/or cases. This trolley (cart) can be closed or open (open trolleys are usually covered with fabric during transport). |
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
- true
- 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 |
| 00841983104329 | Neurofax | NIHON KOHDEN AMERICA, INC. | OLT | 2021-08-06 |
| 05694110068057 | Stratus EEG | Kvikna Medical ehf. | OLT | 2021-01-28 |
| 05694110068064 | Stratus EEG | Kvikna Medical ehf. | OLT | 2021-01-28 |
| 05694110068071 | Stratus EEG | Kvikna Medical ehf. | OLT | 2021-01-28 |
| B485VIS100 | CNS Envision | MOBERG RESEARCH INC | OLT | 2020-10-28 |
| 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 |
| 00840067102718 | Cascade IOMAX Intraoperative Monitor | CADWELL INDUSTRIES, INC. | OLT | 2019-07-09 |
| 00840067102688 | IOMAX Adapter | CADWELL INDUSTRIES, INC. | OLT | 2019-05-13 |
| 00869732000135 | Persyst Mobile App | PERSYST DEVELOPMENT CORP | OLT | 2019-04-08 |
| 00840067102251 | Apollo | CADWELL INDUSTRIES, INC. | OLT | 2018-08-21 |
| 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 |