Catalog Number

PFM2CT5TL

Brand Name

primePICC

Version/Model Number

PFM2CT5TL

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

K110914,K110914,K110914

Product Code

LJS

Product Code Name

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

Public Device Record Key

86f99dcb-137f-46d6-985b-d2e1edf1ad68

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

January 19, 2017

Package DI Number

20813623013791

Quantity per Package

4

Contains DI Package

10813623013794

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-