Catalog Number

54-5030

Brand Name

DeRoyal

Version/Model Number

54-5030

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

KYX

Product Code Name

DISPENSER, LIQUID MEDICATION

Public Device Record Key

a71420c9-556f-413f-88f6-f956598c3918

Public Version Date

July 20, 2021

Public Version Number

1

DI Record Publish Date

July 12, 2021

Package DI Number

50749756767922

Quantity per Package

100

Contains DI Package

00749756767927

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case