Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

47-003

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)

Yes

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

0b964b86-d5fb-4c90-a1be-72d2edb5c715

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

50749756043743

Quantity per Package

50

Contains DI Package

00749756043748

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case