CONTROL LIQUID, OXICOM, BOX 0034091.000

GUDID B154O00340910000

Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring

WATERS MEDICAL SYSTEMS, LLC

Intracardiac oximeter

• Primary Device ID: B154O00340910000
• NIH Device Record Key: da5b1a8f-0f8d-4e0f-bf79-946b9004cb74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTROL LIQUID, OXICOM, BOX
• Version Model Number: CONTROL LIQUID, OXICOM, BOX
• Catalog Number: 0034091.000
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 507-288-7777
• Email: info@wtrs.com
• Phone: 507-288-7777
• Email: info@wtrs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B154O00340910000 [Primary]

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-21
• Device Publish Date: 2017-02-12

Devices Manufactured by WATERS MEDICAL SYSTEMS, LLC

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• 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: 2019-03-21Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring
• 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