Duns Number:057827420
Device Description: 2 UNIT RED CELL SET W/RC2H FIL
Catalog Number
-
Brand Name
MCS+ (LN8150) RBC APHERESIS
Version/Model Number
0832F-00
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
BK060023,BK060023
Product Code
GKT
Product Code Name
Separator, automated, blood cell, diagnostic
Public Device Record Key
0c169ca2-23d8-4720-8bc0-fa7ff26cd9e1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 08, 2017
Package DI Number
30812747013516
Quantity per Package
8
Contains DI Package
10812747013512
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |
| U | Unclassified | 2 |