Duns Number:057827420
Device Description: TPE Disposable,225mLLathamBwl
Catalog Number
-
Brand Name
HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM
Version/Model Number
00980-00
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
K953681,K953681
Product Code
LKN
Product Code Name
SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
Public Device Record Key
5b69761e-4327-46d2-95d3-01ac15266e8d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 08, 2017
Package DI Number
30812747012076
Quantity per Package
8
Contains DI Package
10812747012072
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 |