Duns Number:794519020
Device Description: Plasma Transfer Sets with Two Spikes. Sterile Fluid Path
Catalog Number
4C2243
Brand Name
NA
Version/Model Number
4C2243
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 28, 2018
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
-
Product Code
KSB
Product Code Name
Set, Transfer (Blood/Plasma)
Public Device Record Key
312db0ab-9cd7-453a-83ee-763111e560be
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
20811137010701
Quantity per Package
48
Contains DI Package
10811137010704
Package Discontinue Date
May 28, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
| 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. | 8 |