Duns Number:005146311
Device Description: Solution Set with DUO-VENT Spike, Polyethylene Lined Tubing, Non-DEHP Pump Segment, Luer A Solution Set with DUO-VENT Spike, Polyethylene Lined Tubing, Non-DEHP Pump Segment, Luer Activated Valve, Male Luer Lock Adapter, 117" 2.6m approx., 10 drops/mL approx.
Catalog Number
2R8875
Brand Name
CLEARLINK/DUO-VENT
Version/Model Number
2R8875
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"
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
K112893,K180739,K112893,K180739
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
2ea9d781-e372-4051-9a6c-510b14fae7f2
Public Version Date
October 19, 2022
Public Version Number
6
DI Record Publish Date
July 11, 2017
Package DI Number
50085412565632
Quantity per Package
48
Contains DI Package
00085412565637
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |