Duns Number:315654579
Device Description: Therapeutic plasma exchange, disposable variant of 9400401 (Therapeutic plasma exchange, r Therapeutic plasma exchange, disposable variant of 9400401 (Therapeutic plasma exchange, red blood cell exchange).
Catalog Number
9400451
Brand Name
TPE Plasma Exchange Set
Version/Model Number
9400451
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
K060734,K060734
Product Code
LKN
Product Code Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Public Device Record Key
574d3266-5468-4759-95a6-a99527552009
Public Version Date
September 03, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
04086000901550
Quantity per Package
5
Contains DI Package
04086000901543
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |