Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

89-9794

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)

-

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

403a4edd-4c42-4efd-a543-65c8345b966b

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

January 21, 2018

Package DI Number

50749756943555

Quantity per Package

100

Contains DI Package

00749756943550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case