Duns Number:830767898
Device Description: LIFESHIELD Primary PLUM MICRODRIP 50 mL Burette Set Prepierced Injection Site, 0.2 Micron LIFESHIELD Primary PLUM MICRODRIP 50 mL Burette Set Prepierced Injection Site, 0.2 Micron Filter, Prepierced Y-Site, 101 Inch, Non-DEHP
Catalog Number
1137405
Brand Name
Plum
Version/Model Number
1137405
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
2557944a-eb29-4c2d-bf19-62a6f476d79d
Public Version Date
July 10, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
20887787006494
Quantity per Package
24
Contains DI Package
10887787006497
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 |