Duns Number:480797856
Device Description: Stand alone monitor with colour display for continuous non-invasive vital parameter monito Stand alone monitor with colour display for continuous non-invasive vital parameter monitoring, with integrated docking station for sensor storage and calibration.
Catalog Number
-
Brand Name
SenTec Digital Monitor (with activated PO2 channel)
Version/Model Number
SDM-PO2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2020
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
K041548,K071672,K101690,K151329
Product Code
DPZ
Product Code Name
Oximeter, Ear
Public Device Record Key
bb2184e3-1e78-423a-b5d3-564d7ff90540
Public Version Date
May 06, 2021
Public Version Number
4
DI Record Publish Date
August 31, 2016
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. | 38 |