Duns Number:315654579
Device Description: For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Steril For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Sterile Fluid Path.
Catalog Number
X6R2339
Brand Name
AMICUS Exchange Kit
Version/Model Number
X6R2339
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,K111702
Product Code
LKN
Product Code Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Public Device Record Key
00c008cf-c68d-4a80-abb8-da5b90a910a0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 05, 2016
Package DI Number
14086000100158
Quantity per Package
6
Contains DI Package
04086000100151
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
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 |