Catalog Number

-

Brand Name

Regard™

Version/Model Number

303408

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

822ae1b1-2c38-4ee2-aa24-b646c05ed4c1

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

October 30, 2019

Package DI Number

10326053105309

Quantity per Package

30

Contains DI Package

20326053105306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-