Duns Number:044611812
Device Description: PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Basic Kit, 4F PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Basic Kit, 4F Dual-Lumen 55cm
Catalog Number
1274118
Brand Name
PowerPICC SV Catheter
Version/Model Number
1274118
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
1c5512d2-2b3d-4559-9155-7160df630ec2
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2015
Package DI Number
10801741086912
Quantity per Package
5
Contains DI Package
00801741086915
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |