Duns Number:005146311
Device Description: 12% Sodium Chloride Processing Solution, 150 mL
Catalog Number
4B7874Q
Brand Name
NA
Version/Model Number
4B7874Q
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KSW
Product Code Name
SYSTEM, PROCESSING FOR FROZEN BLOOD
Public Device Record Key
e0030621-82f1-4e0e-adcf-8e53d9919708
Public Version Date
October 18, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50085412010729
Quantity per Package
36
Contains DI Package
00085412010724
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |