Catalog Number

384584

Brand Name

L-CathTM PICC D/L

Version/Model Number

16GA (5F) x 60cm

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"

-

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

9bc0c8b9-95ee-4ba9-a8fb-58a10a7351dc

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

20886333209990

Quantity per Package

5

Contains DI Package

00886333209996

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box