Catalog Number

MR17035206

Brand Name

PRO-PICC®CT

Version/Model Number

MR17035206

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

8c6ba2eb-451b-4689-83d5-d5be554dc95e

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

May 14, 2019

Package DI Number

50884908140397

Quantity per Package

5

Contains DI Package

00884908140392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box