Duns Number:079443785
Device Description: The T- Oxi device indicated for use in non- The vital signs monitor is a portable device i The T- Oxi device indicated for use in non- The vital signs monitor is a portable device invasively measuring and displaying functional indicated for use in non-invasively oxygen saturation of arterial hemoglobin (SpO2 ), measuring and displaying functional oxygen pulse rate (PR), Non-invasive measurement of saturation of arterial hemoglobin blood pressure (NIBP) of adult patients in (SpO2 ), pulse rate (PR), Non-invasive medical facilities, measurement of blood pressure (NIBP) of TheTM-Oxi device is intended for spot-checking adult and pediatric patients in hospitals, of patients. medical facilities, and sub-acute environments. The vital sign monitor is intended for spot-checking and/or continuous monitoring of patients.
Catalog Number
-
Brand Name
TM-Oxi System
Version/Model Number
B001
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"
-
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
K130056
Product Code
MWI
Product Code Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Public Device Record Key
c3d26ae8-c4a8-4028-9a53-5660e13d790c
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
January 16, 2019
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. | 4 |