Oxicom 2100 Oximeter 0007290.000

GUDID B154O00072900000

Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital par

WATERS MEDICAL SYSTEMS, LLC

Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter Intracardiac oximeter
Primary Device IDB154O00072900000
NIH Device Record Key94e80119-2e6d-4409-a1c5-a2f268be4833
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxicom 2100 Oximeter
Version Model NumberOxicom 2100
Catalog Number0007290.000
Company DUNS556957871
Company NameWATERS MEDICAL SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com
Phone507-288-7777
Emailinfo@wtrs.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB154O00072900000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2017-02-12

Devices Manufactured by WATERS MEDICAL SYSTEMS, LLC

B15431800030050 - RM3 Filter2019-03-21 RM3 Accessory - Filter
B154O00067900000 - Oxicom 3000 Oximeter2019-03-21 Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this
B154O00072900000 - Oxicom 2100 Oximeter2019-03-21Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital par
B154O00072900000 - Oxicom 2100 Oximeter2019-03-21 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 plugs2019-03-21 Box containing 100 cuvettes and 100 cuvette plugs for use with Oxicom oximeter.
B154O0010391CUVEACH00 - CUVETTES DC-80 Box 100 cuvettes2019-03-21 Disposable cuvettes for use with the Oxicom oximeter.
B154O00340910000 - CONTROL LIQUID, OXICOM, BOX2019-03-21 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 vial2019-03-21 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 vial2019-03-21 Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three l

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