Duns Number:141588017
Device Description: LIFESHIELD, Primary PLUM Set, Prepierced Secondary Port, Prepierced Y-Site, Secure Lock, 1 LIFESHIELD, Primary PLUM Set, Prepierced Secondary Port, Prepierced Y-Site, Secure Lock, 104 Inch
Catalog Number
1100378
Brand Name
Plum
Version/Model Number
1100378
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
5433db2d-bf98-4d2e-9251-152fc81afa33
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
Package DI Number
20887787005060
Quantity per Package
48
Contains DI Package
10887787005063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |