Duns Number:929856680
Device Description: The T-Stat 2.0 Microvascular Tissue Oximeter provides a continuous, non-invasive, and loca The T-Stat 2.0 Microvascular Tissue Oximeter provides a continuous, non-invasive, and localized measurement of the microvascular hemoglobin oxygen saturation. sensitive to regional and global reduced flow or no-flow ischemia. It is intended for use as an adjunct monitor of the localized oxygen saturation of blood in microvasular tissue spaces.
Catalog Number
T-Stat 2.0
Brand Name
Spectros T-Stat
Version/Model Number
T-Stat 2.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192322
Product Code
MUD
Product Code Name
Oximeter, Tissue Saturation
Public Device Record Key
ff4f772c-e8d6-41db-a953-df251f8bc07e
Public Version Date
October 29, 2019
Public Version Number
1
DI Record Publish Date
October 21, 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. | 6 |