Duns Number:005146311
Device Description: Non-DEHP CONTINU-FLO Solution Set, 68" 1.7m approx., 2 Luer Activated Valves, Male Luer Lo Non-DEHP CONTINU-FLO Solution Set, 68" 1.7m approx., 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, Non-DEHP Large Bore Stopcock Extension Set, 59" 1.5m, 8.7 mL approx., Large Bore Stopcock Manifold, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 10 drops/mL approx.
Catalog Number
2R8454
Brand Name
CLEARLINK/CONTINU-FLO
Version/Model Number
2R8454
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
K130245,K130245
Product Code
FMG
Product Code Name
Stopcock, i.V. Set
Public Device Record Key
7fcfe588-95fd-4176-bff6-c36e5b7f863f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 11, 2017
Package DI Number
50085412565649
Quantity per Package
48
Contains DI Package
00085412565644
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 |