| Primary Device ID | 35060441917530 |
| NIH Device Record Key | a1014d40-c0af-402e-a111-6ffdb96a0037 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PhysioFlow |
| Version Model Number | HTFS50PF |
| Catalog Number | 4012871C |
| Company DUNS | 671405566 |
| Company Name | NISSHA MEDICAL TECHNOLOGIES LTD |
| Device Count | 7 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060441917539 [Unit of Use] |
| GS1 | 15060441917536 [Primary] |
| GS1 | 35060441917530 [Package] Contains: 15060441917536 Package: Box [140 Units] In Commercial Distribution |
| GS1 | 55060441917534 [Package] Package: Case [1680 Units] In Commercial Distribution |
| DRX | Electrode, Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-14 |
| Device Publish Date | 2020-05-06 |
| 35060842920146 - Dräger | 2024-03-11 ECG Electrode |
| 35060842920153 - Dräger | 2024-03-11 ECG Electrode |
| 35060842920023 - Stryker | 2022-08-25 Neutral Electrodes intended to be used in combination with the device “Stryker MultiGen 2 RF Generator” |
| 15060441917628 - Boston Scientific | 2022-06-29 Neutral Electrode |
| 15060441917642 - Boston Scientific | 2022-06-29 Neutral Electrode |
| 35060441919992 - Maestro | 2022-02-04 Neutral Electrode |
| 35060441919244 - Swaroplate | 2021-05-07 Neutral Electrode |
| 35060441919251 - Swaroplate | 2021-05-07 Neutral Electrode |