Catalog Number

01-561

Brand Name

VERIDIAN

Version/Model Number

01-561

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

eb1705d9-d32d-4572-add2-412238f23b7e

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

July 26, 2019

Package DI Number

10845717006436

Quantity per Package

12

Contains DI Package

30845717006430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER