Duns Number:692097404
Device Description: The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therap The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinical setting.
Catalog Number
-
Brand Name
Plasmaflo
Version/Model Number
OP-05W(A)
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
-
Product Code
MDP
Product Code Name
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
Public Device Record Key
5ee01d68-f06a-4ee5-b02a-554d50793406
Public Version Date
December 14, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2014
Package DI Number
24537693005369
Quantity per Package
3
Contains DI Package
04537693005365
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton (inner)
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |