Duns Number:094651270
Device Description: A Single-Lumen Polyurethane Peripherally Inserted Central Catheter and Peel-Away Introduce A Single-Lumen Polyurethane Peripherally Inserted Central Catheter and Peel-Away Introducer, 1.1 French
Catalog Number
PB-1PP
Brand Name
PICC-NATE
Version/Model Number
Basic
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K001874
Product Code
LJS
Product Code Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Public Device Record Key
1be075ac-0f8f-4acb-a1aa-42c0f7e3fb2d
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
December 18, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |