Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

35-401065

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

DRS

Product Code Name

TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Public Device Record Key

4c23cb8e-383c-4ec4-a1bb-c908870d0d5b

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

December 29, 2016

Package DI Number

50749756914630

Quantity per Package

20

Contains DI Package

00749756914635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case