Duns Number:140727624
Device Description: L-Cath™ PICC S/L Peripherally Inserted Central Catheter 26ga (1.9F) 0.60mm x 30cm with Sta
Catalog Number
384549
Brand Name
L-Cath™ PICC
Version/Model Number
384549
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
7c051aee-7ac0-48d1-b1e2-3e072bf1c627
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
20886333209952
Quantity per Package
5
Contains DI Package
00886333209958
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 |