Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS9019

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K942543,K942543

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

b0b91c96-cdb5-44bd-84d0-8fcdbf765492

Public Version Date

December 14, 2020

Public Version Number

3

DI Record Publish Date

January 13, 2017

Package DI Number

10849027000023

Quantity per Package

50

Contains DI Package

00849027000026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case