Duns Number:134139174
Device Description: PRESEP OXIMETRY CATHETER 8.5F 16CM W/O THROMBOSHIELD
Catalog Number
X3816S
Brand Name
PRESEP
Version/Model Number
X3816S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 13, 2016
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
For Single-Use
Yes
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
K053609,K110167
Product Code
DQE
Product Code Name
CATHETER, OXIMETER, FIBEROPTIC
Public Device Record Key
c74e2d75-cbe4-4c61-9361-c92c7d016c3e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 03, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |