Duns Number:791238046
Device Description: 1.9Fr Single Lumen Silicone PIC Catheter (30cm)
Catalog Number
-
Brand Name
NA
Version/Model Number
S1PIC1.9-C
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
K093252,K093252
Product Code
LJS
Product Code Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Public Device Record Key
5ac25e8e-8d4f-4315-a670-3c7056be9c16
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
10858778006024
Quantity per Package
5
Contains DI Package
00858778006027
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |