| Primary Device ID | 00841983104206 |
| NIH Device Record Key | a969945c-6e56-4aa9-9ebe-f595606efd9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patient Triage Solution |
| Version Model Number | SVM-NK-R-EX-HP-ZA |
| Catalog Number | SVM-NK-R-EX-HP-ZA |
| Company DUNS | 021063219 |
| Company Name | NIHON KOHDEN AMERICA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com | |
| Phone | +1(800)325-0283 |
| info@nkusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841983104206 [Primary] |
| DQA | Oximeter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-19 |
| Device Publish Date | 2020-04-21 |
| 00841983104220 | SVM 7230A Portable Vital Signs Monitor with an eight-inch color display with Masimo SpO2, iNIBP |
| 00841983104213 | SVM 7250A Portable Vital Signs Monitor with an eight-inch color display with Nellcor SpO2, iNIB |
| 00841983104206 | SVM 7260A portable Vital Signs Monitor with an eight-inch color display with Nihon Kohden SpO2 |