Duns Number:556957871
Device Description: Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical informat 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. OXICOM 3000 WHOLE BLOOD OXIMETER. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood and calculate the arterial and venous content difference (AVO2).
Catalog Number
0006790.000
Brand Name
Oxicom 3000 Oximeter
Version/Model Number
Oxicom 3000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
79213ab7-c89d-451a-999a-850274cf695c
Public Version Date
March 21, 2019
Public Version Number
3
DI Record Publish Date
February 12, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |