Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

54-5115R

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

FPD

Product Code Name

TUBE, FEEDING

Public Device Record Key

f4109e64-a95b-4e37-9602-c729729fc6e5

Public Version Date

July 23, 2021

Public Version Number

3

DI Record Publish Date

April 18, 2017

Package DI Number

50749756767823

Quantity per Package

100

Contains DI Package

00749756767828

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case