Catalog Number

89-10342

Brand Name

DeRoyal

Version/Model Number

89-10342

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)

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

2a26a689-0ebc-45f6-80e5-81a96a4e5a8d

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 07, 2021

Package DI Number

50749756987924

Quantity per Package

40

Contains DI Package

00749756987929

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case