Catalog Number

-

Brand Name

Extra Large D-ring Cuff, Telehealth, Blood Pressure Monitor

Version/Model Number

HEM-RXL31

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

K163235,K163235

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

0440a2f8-0742-464e-9aa5-be6cfa017b85

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

April 26, 2017

Package DI Number

10073796842311

Quantity per Package

10

Contains DI Package

00073796842314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case