Catalog Number

-

Brand Name

Panasonic

Version/Model Number

EW3109

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

K991458,K991458

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

08ce9f55-9cca-4576-ba02-7ad1cb74f811

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

November 25, 2016

Package DI Number

10851439007026

Quantity per Package

5

Contains DI Package

00851439007029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-