Duns Number:315654579
Device Description: For Administration of Blood and Blood Components During a Therapeutic Plasma Exchange (TPE For Administration of Blood and Blood Components During a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) Therapeutic Apheresis Procedure. For use with the AMICUS separator. Sterile Fluid Path.
Catalog Number
X6C2170
Brand Name
Blood Component Filter Set with Vented Spike and Luer Adapter
Version/Model Number
X6C2170
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"
-
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
K111702,K180615,K111702,K180615,K111702,K180615
Product Code
LKN
Product Code Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Public Device Record Key
5bd37038-ad79-4921-b8b2-5afd80277c46
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
February 20, 2019
Package DI Number
14052682031714
Quantity per Package
48
Contains DI Package
04052682031717
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |