Catalog Number

PFM2CT6DN

Brand Name

PICC Prime

Version/Model Number

PFM2CT6DN

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

K083873,K083873,K083873

Product Code

LJS

Product Code Name

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

Public Device Record Key

0ff039ba-5cc1-4898-b4a4-d8a44972a878

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

January 19, 2017

Package DI Number

20813623013777

Quantity per Package

4

Contains DI Package

10813623013770

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-