Duns Number:328712260
Device Description: Plasma Control Level II, Mycophenolic acid in plasma/serum
Catalog Number
0043
Brand Name
Plasma Control
Version/Model Number
0043
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
8dcfa750-97c5-4a4a-bf15-00964277f187
Public Version Date
August 07, 2020
Public Version Number
1
DI Record Publish Date
July 30, 2020
Package DI Number
04250317508560
Quantity per Package
10
Contains DI Package
04250317543684
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 | 455 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |