Catalog Number

-

Brand Name

Nihon Kohden

Version/Model Number

A0001D06

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170536,K170536

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Public Device Record Key

f5d90a76-5a21-4a26-8e57-4e095a20a815

Public Version Date

October 25, 2021

Public Version Number

2

DI Record Publish Date

July 06, 2018

Package DI Number

16946725590819

Quantity per Package

10

Contains DI Package

06946725527030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-