Catalog Number

18601

Brand Name

DISP ECG LW,5LD,PINCH TO MULTI,INTERMED

Version/Model Number

DLW-05BM-40AM-3000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 28, 2017

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

DSA

Product Code Name

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

Public Device Record Key

0e0b95c8-632c-4b9c-b740-4161d8277c3e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

90840828101427

Quantity per Package

2

Contains DI Package

90840828101014

Package Discontinue Date

December 28, 2017

Package Status

Not in Commercial Distribution

Package Type

-