Duns Number:017246562
Device Description: DIALYSIS ACCESSORY PACK W/O CATHETER
Catalog Number
MNS10750A
Brand Name
Centurion
Version/Model Number
MNS10750A
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FKG
Product Code Name
TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS
Public Device Record Key
0e3c1cbb-e96d-43ef-9ee3-f684f799976d
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 24, 2021
Package DI Number
00653160348286
Quantity per Package
5
Contains DI Package
10653160348283
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 | 6043 |
2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
U | Unclassified | 1 |