Duns Number:140727624
Device Description: L-Cath™ Midline S/L Midline Catheter Basic Kit 20GA (3F) x 20cm
Catalog Number
384631
Brand Name
L-Cath™ Midline S/L Midline Catheter Basic Kit
Version/Model Number
384631
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
FOZ
Product Code Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Public Device Record Key
21e20f9d-1853-457e-a4bd-e17eb1baa6de
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
20886333210026
Quantity per Package
5
Contains DI Package
00886333210022
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |