Duns Number:140727624
Device Description: Peripherally Inserted Central Catheter
Catalog Number
384464
Brand Name
L-Cath™ PICC S/L
Version/Model Number
18GA (3.5F) 1.15mm x 60cm
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"
-
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
5f493b46-5b0c-45fc-bfa2-edb8dc71c511
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
October 23, 2015
Package DI Number
20886333209839
Quantity per Package
5
Contains DI Package
00886333209835
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 |