Duns Number:005083209
Device Description: Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar
Catalog Number
2R8864
Brand Name
CLEARLINK/BURETROL
Version/Model Number
2R8864
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)
Yes
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
K123874,K123874
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
c32b2751-444b-4fe8-a326-957846f6bb97
Public Version Date
October 08, 2019
Public Version Number
1
DI Record Publish Date
September 30, 2019
Package DI Number
50085412565700
Quantity per Package
48
Contains DI Package
00085412565705
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |