Catalog Number

Yes

Brand Name

hysure

Version/Model Number

U82W

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

K160019,K160019

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

87c6835d-ba53-41f1-ae07-631312b8324e

Public Version Date

August 24, 2022

Public Version Number

1

DI Record Publish Date

August 16, 2022

Package DI Number

16953825906228

Quantity per Package

30

Contains DI Package

06953825906221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton