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 | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
Phone | 507-288-7777 |
info@wtrs.com | |
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 |
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 |