Duns Number:002054419
Device Description: Two empty transfer bags with two spikes and luer adapter and associated tubing for washing Two empty transfer bags with two spikes and luer adapter and associated tubing for washing blood and cellular components.
Catalog Number
791-03
Brand Name
Pall® CellWash/Infusion Bag Set
Version/Model Number
791-03
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"
Yes
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
-
Product Code
KSR
Product Code Name
CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS
Public Device Record Key
659e70d2-018a-4fb0-9932-5fcdb1e0db57
Public Version Date
September 23, 2019
Public Version Number
3
DI Record Publish Date
June 01, 2016
Package DI Number
30636207302435
Quantity per Package
24
Contains DI Package
00636207302434
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |