Catalog Number

01616

Brand Name

Set of electrodes

Version/Model Number

V1.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 19, 2019

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K014063,K014063,K014063

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

d0a553fc-5fe8-490d-b38d-b4b4be4e9f03

Public Version Date

November 20, 2019

Public Version Number

4

DI Record Publish Date

October 27, 2016

Package DI Number

09120073930477

Quantity per Package

10

Contains DI Package

09120073930460

Package Discontinue Date

November 19, 2019

Package Status

Not in Commercial Distribution

Package Type

-