Duns Number:057827420
Device Description: RBC DE-GLYCEROL./CELL WASH SET
Catalog Number
-
Brand Name
HAEMONETICS ACP 215 SYSTEM
Version/Model Number
00235-00
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
BK060008,BK060008
Product Code
KSW
Product Code Name
SYSTEM, PROCESSING FOR FROZEN BLOOD
Public Device Record Key
69bd7f5c-cf49-41aa-8101-5628c36f88f2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 07, 2017
Package DI Number
30812747015015
Quantity per Package
20
Contains DI Package
10812747015011
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 |