Duns Number:315654579
Device Description: Adjustable Automatic Donor Scale Support Stand
Catalog Number
4R4408
Brand Name
Fresenius Kabi Adjustable Automatic Donor Scale Support Stand
Version/Model Number
Version A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KSQ
Product Code Name
Device, Blood Mixing And Blood Weighing
Public Device Record Key
becfc581-72b4-47a3-9648-9edd9a9c69fc
Public Version Date
August 26, 2021
Public Version Number
1
DI Record Publish Date
August 18, 2021
Package DI Number
10810020440345
Quantity per Package
1
Contains DI Package
00810020440348
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |
U | Unclassified | 2 |