| Primary Device ID | 04931921112830 |
| NIH Device Record Key | 901d3c61-7982-4f06-812a-398058e1e8e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | KC-001A |
| Catalog Number | KC-001A |
| Company DUNS | 690568050 |
| Company Name | NIHON KOHDEN CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)325-0283 |
| info@nkusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04931921112830 [Primary] |
| GWC | ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-05 |
| 04931921044353 - cap-ONE` | 2024-07-01 Airway adapter for adult and child |
| 04931921017524 - NA | 2024-02-02 Receiver unit for ZS, ZM series |
| 04931921017159 - CNS-2101 Central Monitor | 2023-11-07 Central Monitor |
| 04931921007723 - Nihon Kohden, EEG-1200A Series Neurofax | 2023-10-09 Cart, used with EEG-1200A, works with standard and optional accessories |
| 04931921007730 - Nihon Kohden, EEG-1200A Series Neurofax | 2023-10-09 Cart, Compact type, used with EEG-1200A, works with standard and optional accessories |
| 04931921017166 - CNS-2101 Central Monitor | 2023-10-09 Central Monitor |
| 04931921010235 - cap-ONE | 2023-05-30 cap-ONE Nasal Adapter, Adult |
| 04931921010273 - cap-ONE | 2023-05-30 cap-ONE Nasal Adapter, Adult, w/ Oxygen tube |