Duns Number:315654579
Device Description: For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile Fluid Path.
Catalog Number
X6C2172
Brand Name
Waste Transfer Set
Version/Model Number
X6C2172
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
K180615,K180615
Product Code
LKN
Product Code Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Public Device Record Key
0c40972d-bb1c-4e11-9bfc-e56bc3a6cd6e
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 20, 2019
Package DI Number
14052682031721
Quantity per Package
20
Contains DI Package
04052682031724
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 |