Catalog Number

-

Brand Name

TELEHEALTH BLOOD PRESSURE MONITOR BLE-XL

Version/Model Number

HEM-9210T

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)

-

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

K163235,K163235

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

e4d34c5f-6800-4ba0-b51c-4276cc9961f5

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

April 26, 2017

Package DI Number

10073796921009

Quantity per Package

10

Contains DI Package

00073796921002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case