Catalog Number

-

Brand Name

Regard™

Version/Model Number

370003

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

9adff94b-e7b1-45ba-b433-5b934576114c

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

October 30, 2019

Package DI Number

10326053116084

Quantity per Package

20

Contains DI Package

00326053116087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-