Duns Number:218635156
Device Description: The Oxyless blood tubing set comprises disposable blood tubing lines intended to provide e The Oxyless blood tubing set comprises disposable blood tubing lines intended to provide extra-corporeal access to the patient's blood during hemodialysis.
Catalog Number
-
Brand Name
Oxyless
Version/Model Number
CK84/14-F
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
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
K150304,K150304
Product Code
FJK
Product Code Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Public Device Record Key
e3aae127-4699-4242-bcfd-0ddce3320c1f
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
October 24, 2016
Package DI Number
15060493650009
Quantity per Package
15
Contains DI Package
05060493650002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |