| Primary Device ID | 00841983104176 |
| NIH Device Record Key | c7092baa-9e34-47cc-817a-1575bbecedbd |
| Commercial Distribution Discontinuation | 2019-01-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | RNS-6803-7460 |
| Catalog Number | RNS-6803-7460 |
| Company DUNS | 021063219 |
| Company Name | NIHON KOHDEN AMERICA, INC. |
| 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 | false |
| Serial Number | true |
| 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 |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| 10841983103947 - NA | 2023-10-09 PAPER, ECG1250, 9020, 10 PADS |
| 10841983103954 - NA | 2023-10-09 PAPER, ECG1350, 9130, 10 PADS |
| 10841983103930 - NA | 2023-08-17 PAPER, ECG-1550A, 10 PADS |
| 00841983104336 - NK-HealthProtect Wireless Surge Solution | 2021-12-31 Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring |
| 10841983102667 - NA | 2021-11-10 SpO2 probe Adults, child (from 15 to 50 kg) Finger, disposable |
| 10841983102674 - NA | 2021-11-10 SpO2 probe Child, infant (from 3 to 15 kg) Toe, disposable |
| 10841983102704 - BluPRO® | 2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 80cm cable |
| 10841983102711 - BluPRO® | 2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 160cm cable |