Duns Number:123407392
Device Description: Pulse Oximeter Sensor - Finger Probe
Catalog Number
SEDOXFP
Brand Name
SEDASYS
Version/Model Number
SEDOXFP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 15, 2017
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
-
Product Code
PDR
Product Code Name
Computer-assisted personalized sedation system
Public Device Record Key
224438ab-7fc5-43dc-9387-c6cf1d283eae
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 15, 2016
Package DI Number
30705036003810
Quantity per Package
6
Contains DI Package
20705036003813
Package Discontinue Date
June 15, 2017
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 16 |