Duns Number:360624720
Device Description: EXT SET W/FLOW CNTRL,NDLELESS,Y-SITE 14
Catalog Number
MFS141
Brand Name
MaxGuard
Version/Model Number
MFS141
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
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
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
ec5bd853-94c0-4ccb-8343-7480846cc527
Public Version Date
January 13, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
50885403236479
Quantity per Package
50
Contains DI Package
10885403236471
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
| 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. | 43 |