Duns Number:393020474
Device Description: The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or w The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.
Catalog Number
114093
Brand Name
PRISMAFLEX TPE 2000 SET
Version/Model Number
114093
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
P830063,P830063,P830063,P830063
Product Code
MDP
Product Code Name
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
Public Device Record Key
214a1eb8-bc63-46c4-b586-c4d704367679
Public Version Date
October 11, 2022
Public Version Number
7
DI Record Publish Date
March 23, 2017
Package DI Number
37332414111039
Quantity per Package
4
Contains DI Package
07332414111038
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |