Duns Number:140727624
Device Description: L-Cath PICC S/L Peripherally Inserted Central Catheter 26Ga (1.9F) 0.60mm x 30cm
Catalog Number
384539
Brand Name
L-Cath™ S/L PICC S/L
Version/Model Number
26GA (1.9F) x 30cm
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
LJS
Product Code Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Public Device Record Key
57153105-c795-4815-924f-088c81e0616f
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
October 23, 2015
Package DI Number
20886333209938
Quantity per Package
5
Contains DI Package
00886333209934
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 |