Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

TM9538CS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

PEZ

Product Code Name

Central Venous Catheter Dressing Change Kit

Public Device Record Key

f87e81f8-e795-41d3-b9a6-16f0f125913f

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

January 21, 2020

Package DI Number

M752TM9538CS5

Quantity per Package

50

Contains DI Package

M752TM9538CS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box