Duns Number:830767898
Device Description: Primary PLUM Set 0.2 Micron Filter, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 112 I Primary PLUM Set 0.2 Micron Filter, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 112 Inch (previously Hospira product)
Catalog Number
1495488
Brand Name
Plum
Version/Model Number
1495488
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
K141789,K141789
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
db3d9d67-2350-4d84-88ae-f058d1c15260
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
May 31, 2018
Package DI Number
20887787003233
Quantity per Package
24
Contains DI Package
10887787003236
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. | 2 |