RM3 RENAL PERFUSION MONITOR 3900040.004

GUDID B154R39000400040

Kidney donor-organ preservation/transport perfusion set

Primary Device ID	B154R39000400040
NIH Device Record Key	3ac22d92-1f1d-4ad0-8db2-6de71e28a787
Commercial Distribution Status	In Commercial Distribution
Brand Name	RM3 RENAL PERFUSION MONITOR
Version Model Number	RM3
Catalog Number	3900040.004
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	B154R39000400040 [Primary]

KDN	System, Perfusion, Kidney

Steralize Prior To Use	false
Device Is Sterile	false

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