Catalog Number

-

Brand Name

Automatic Blood Pressure Monitor with memory and Printer

Version/Model Number

HEM-705CPN

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

K930798,K930798,K930798

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

9e98dfd4-cd43-4c09-8a56-097b0133c47d

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

January 25, 2017

Package DI Number

10073796705364

Quantity per Package

3

Contains DI Package

00073796705367

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton