| Primary Device ID | B154R39100010043 |
| NIH Device Record Key | 91f2c804-3a6f-4061-8fd1-ff414755e0f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RM3 Tool Kit |
| Version Model Number | RM3 Tool Kit |
| Catalog Number | 3910001.004 |
| Company DUNS | 556957871 |
| Company Name | WATERS MEDICAL SYSTEMS, LLC |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B154R39100010043 [Primary] |
| KDN | System, Perfusion, Kidney |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2017-03-27 |
| B15431800030050 - RM3 Filter | 2019-03-21 RM3 Accessory - Filter |
| B154O00067900000 - Oxicom 3000 Oximeter | 2019-03-21 Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this |
| B154O00072900000 - Oxicom 2100 Oximeter | 2019-03-21 Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this |
| B154O00103910003 - CUVETTES DC-80 Box 100 cuvettes & 100 plugs | 2019-03-21 Box containing 100 cuvettes and 100 cuvette plugs for use with Oxicom oximeter. |
| B154O0010391CUVEACH00 - CUVETTES DC-80 Box 100 cuvettes | 2019-03-21 Disposable cuvettes for use with the Oxicom oximeter. |
| B154O00340910000 - CONTROL LIQUID, OXICOM, BOX | 2019-03-21 Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three l |
| B154O0034091HIG00 - CONTROL LIQUID, OXICOM - High vial | 2019-03-21 Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three l |
| B154O0034091LOW00 - CONTROL LIQUID, OXICOM - Low vial | 2019-03-21 Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three l |