Duns Number:141588017
Device Description: LIFESHIELD LATEX-FREE MICRODRIP SOLUSET 150 mL BURETTE PLUMSET, Convertible Pin, 139 Inch LIFESHIELD LATEX-FREE MICRODRIP SOLUSET 150 mL BURETTE PLUMSET, Convertible Pin, 139 Inch with 4 Prepierced Injection Sites, 0.2 Micron Filter and OPTION-LOK Dual Channel Capped Secondary Port
Catalog Number
1194902
Brand Name
Plum
Version/Model Number
1194902
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
FRN
Product Code Name
Pump, infusion
Public Device Record Key
e5eefbe0-8f5c-40cc-90cc-a31f9282481e
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
20887787006920
Quantity per Package
24
Contains DI Package
10887787006923
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 |