| Primary Device ID | 3930005014 |
| NIH Device Record Key | cfc8b079-0c8f-4e9c-9f00-1f47d5fc6b25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WCM Kit |
| Version Model Number | WCM Kit |
| Catalog Number | 3930005.014 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 507-288-7777 |
| info@wtrs.com | |
| Phone | 507-288-7777 |
| info@wtrs.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | 3930005014 [Package] Contains: B154W39300050123 Package: Case [6 Units] In Commercial Distribution |
| HIBCC | B154W39300050123 [Primary] |
| KDN | System, Perfusion, Kidney |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2017-02-12 |
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| 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 |