Duns Number:005146311
Device Description: Paclitaxel Set, Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.2 Micron Downstream Fi Paclitaxel Set, Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.2 Micron Downstream Filter, Luer Activated Valve, Male Luer Lock Adapter, 107" 2.7m approx., 10 drops/mL approx.
Catalog Number
2R8858
Brand Name
CLEARLINK
Version/Model Number
2R8858
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
K160007,K160007
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
27a56e3c-b20a-4ad6-b887-47836f84fed2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 11, 2017
Package DI Number
50085412565779
Quantity per Package
48
Contains DI Package
00085412565774
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 |