Catalog Number

-

Brand Name

RENPHO

Version/Model Number

B02

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172171,K172171

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

08be8d42-e4a5-409c-8008-a2e2d4439059

Public Version Date

December 20, 2019

Public Version Number

1

DI Record Publish Date

December 12, 2019

Package DI Number

10860002249626

Quantity per Package

30

Contains DI Package

00860002249629

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-