Catalog Number

MRCTP41029

Brand Name

PRO-PICC® CT

Version/Model Number

MRCTP41029

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

Yes

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

60d04e52-a713-410c-bc74-2b4928e89909

Public Version Date

September 20, 2021

Public Version Number

1

DI Record Publish Date

September 10, 2021

Package DI Number

50884908163303

Quantity per Package

3

Contains DI Package

00884908163308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box