Oxicom 2100 Oximeter 0007290.000

GUDID B154O00072900000

Intracardiac oximeter

Primary Device ID	B154O00072900000
NIH Device Record Key	94e80119-2e6d-4409-a1c5-a2f268be4833
Commercial Distribution Status	In Commercial Distribution
Brand Name	Oxicom 2100 Oximeter
Version Model Number	Oxicom 2100
Catalog Number	0007290.000
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	false
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	B154O00072900000 [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