Duns Number:480797856
Device Description: Digital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxid Digital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide and oxygen partial pressure as well as pulse oximetry. Suitable for adult, pediatric and neonatal patients.
Catalog Number
-
Brand Name
OxiVenT™ Sensor
Version/Model Number
OV-A/P/N
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
K041548,K071672,K101690,K151329
Product Code
DPZ
Product Code Name
Oximeter, Ear
Public Device Record Key
998105cb-f465-469a-98db-a9db1b810e6b
Public Version Date
July 06, 2018
Public Version Number
3
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 |