Oxicom 3000 Box Kit 0006790.000

GUDID B154OXIKIT30003

Intracardiac oximeter

Primary Device ID	B154OXIKIT30003
NIH Device Record Key	a589d87f-4b5d-47e0-9443-995394ee9c1e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Oxicom 3000 Box Kit
Version Model Number	Oxicom 3000 Kit
Catalog Number	0006790.000
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	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
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	B154OXIKIT30003 [Primary]

Oximeter

Steralize Prior To Use	false
Device Is Sterile	false

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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