Oxicom 2100 Oximeter

Basic Information

• Brand Name: Oxicom 2100 Oximeter
• Primary DI: B154O00072900000
• Version / Model: Oxicom 2100
• Catalog Number: 0007290.000
• Company Name: WATERS MEDICAL SYSTEMS, LLC
• Labeler DUNS: 556957871
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-12
• Public Version: 5
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 94e80119-2e6d-4409-a1c5-a2f268be4833
• Distribution End Date: 2023-12-15

Device Description

Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital part of any cardiac catheterization laboratory and surgical center. The Waters Oxicom is used to measure over 500,000 patient blood samples annually. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15200	Intracardiac oximeter	A mains electricity (AC-powered) photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation. It is typically used in conjunction with a fibreoptic oximeter catheter (e.g., a Swan-Ganz catheter) that is introduced via a vein in the groin or neck to measure mixed venous oxygen saturation (SvO2) or evaluate intracardiac shunts.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B154O00072900000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K921519	000