Catalog Number

HEM-FL31-B

Brand Name

Omron Easy Wrap Comfit Cuff

Version/Model Number

HEM-FL31-B

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

K133383,K133383

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

3909064e-7b5d-4486-a309-53501928583e

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

May 01, 2019

Package DI Number

10073796361720

Quantity per Package

20

Contains DI Package

00073796361723

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case