Catalog Number

P-2P

Brand Name

PICC-NATE

Version/Model Number

Catheter

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,K001874

Product Code

LJS

Product Code Name

Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Public Device Record Key

4367c8ef-8561-417f-9ff0-1229370c8461

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

H671P2P1

Quantity per Package

10

Contains DI Package

H671P2P0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box