AccessGUDID - DEVICE: Oxicom 2100 Oximeter (B154O00072900000)

GUDID

Device Identifier (DI) Information

Brand Name: Oxicom 2100 Oximeter
Version or Model: Oxicom 2100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0007290.000
Company Name: WATERS MEDICAL SYSTEMS, LLC

Primary DI Number: B154O00072900000
Issuing Agency: HIBCC
Commercial Distribution End Date: December 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 556957871 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K921519	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 94e80119-2e6d-4409-a1c5-a2f268be4833
Public Version Date: December 18, 2023
Public Version Number: 5
DI Record Publish Date: February 12, 2017