Oxicom 3000 Box Kit 0006790.000

GUDID B154OXIKIT30003

Oxicom 3000 Box Kit containing 100ct cuvette/plugs & QC 1,2,3 sticks

WATERS MEDICAL SYSTEMS, LLC

Intracardiac oximeter
Primary Device IDB154OXIKIT30003
NIH Device Record Keya589d87f-4b5d-47e0-9443-995394ee9c1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxicom 3000 Box Kit
Version Model NumberOxicom 3000 Kit
Catalog Number0006790.000
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 Kittrue
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
HIBCCB154OXIKIT30003 [Primary]

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
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 Oximeter2019-03-21 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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