Duns Number:141588017
Device Description: LIFESHIELD LATEX-FREE MACROBORE PLUMSET EXTENSION SET, 12 Inch with OPTION-LOK Dual Channe LIFESHIELD LATEX-FREE MACROBORE PLUMSET EXTENSION SET, 12 Inch with OPTION-LOK Dual Channel Capped Secondary Port
Catalog Number
1909848
Brand Name
Plum
Version/Model Number
1909848
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
68e1a571-9606-4aed-bd5b-94458dcf450e
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
20887787008702
Quantity per Package
48
Contains DI Package
10887787008705
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 |