Catalog Number

1616

Brand Name

Set of electrodes

Version/Model Number

V1.0

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

Yes

Prescription Use (Rx)

Yes

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

97701745-3fac-4b81-84d7-0c85763fb994

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 04, 2018

Package DI Number

09120073931962

Quantity per Package

12

Contains DI Package

09120073931955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box