Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

32-2085

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

GAZ

Product Code Name

TUBING, NONINVASIVE

Public Device Record Key

01433b7c-cdc5-4c29-b673-492e3e7a0d7c

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

January 10, 2017

Package DI Number

50749756907663

Quantity per Package

20

Contains DI Package

00749756907668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case