Catalog Number

-

Brand Name

BV Medical

Version/Model Number

20-104-014-L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

344dd785-ab6d-4166-ab01-6b56c91b7e17

Public Version Date

December 24, 2018

Public Version Number

4

DI Record Publish Date

April 28, 2017

Package DI Number

00845821029027

Quantity per Package

24

Contains DI Package

00845821001030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-