Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

31-005

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

GAZ

Product Code Name

TUBING, NONINVASIVE

Public Device Record Key

f693d09c-8531-49d7-89ca-1440f7014423

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

50749756034550

Quantity per Package

50

Contains DI Package

00749756034555

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case