Duns Number:005146311
Device Description: Y-Type Blood/Solution Set with Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Lu Y-Type Blood/Solution Set with Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Luer Activated Valves, Male Luer Lock Adapter
Catalog Number
4C8714
Brand Name
CLEARLINK
Version/Model Number
4C8714
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
K993120,K993120
Product Code
BRZ
Product Code Name
Set, blood transfusion
Public Device Record Key
b9d2b041-3b6f-40a0-95bb-ea10d3a50791
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50085412072987
Quantity per Package
48
Contains DI Package
00085412072982
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 |