Duns Number:005146311
Device Description: Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Colla Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 76" 1.9m approx., 10 drops/mL approx.
Catalog Number
2R8401
Brand Name
CLEARLINK
Version/Model Number
2R8401
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
25be7b1d-2f09-4c26-8d4b-83d169186a1f
Public Version Date
April 07, 2021
Public Version Number
7
DI Record Publish Date
July 11, 2017
Package DI Number
50085412565762
Quantity per Package
48
Contains DI Package
00085412565767
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 |