Catalog Number

-

Brand Name

Digital Blood Pressure Monitor

Version/Model Number

7095

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

K171833,K171833

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

a08b9e8f-4be6-4839-8bbb-fdb060832b5f

Public Version Date

January 27, 2021

Public Version Number

1

DI Record Publish Date

January 19, 2021

Package DI Number

00616784709536

Quantity per Package

5

Contains DI Package

00616784709529

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case