Duns Number:141588017
Device Description: CONVERTIBLE DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP
Catalog Number
1972928
Brand Name
Plum
Version/Model Number
1972928
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
3fa82ea4-ce98-4ee6-8ba0-f698c62086ca
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
20887787009006
Quantity per Package
48
Contains DI Package
10887787009009
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |