Duns Number:360624720
Device Description: MaxPlus ectension set with needleless connector and Y-site
Catalog Number
MPX9102-SF-C
Brand Name
MaxPlus
Version/Model Number
MPX9102-SF-C
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
-
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
d3382c81-3a4e-4781-85d7-d753480a22ef
Public Version Date
April 27, 2020
Public Version Number
4
DI Record Publish Date
November 04, 2016
Package DI Number
20885403427975
Quantity per Package
12
Contains DI Package
50885403427976
Package Discontinue Date
-
Package Status
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. | 43 |