Catalog Number

-

Brand Name

BlackBox RPM

Version/Model Number

BPM-102C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

c334b63d-d28c-4ad2-b432-6ea9bc6d6df4

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

August 01, 2021

Package DI Number

B963BB10BPM102C10

Quantity per Package

10

Contains DI Package

B963102C1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton