Catalog Number

-

Brand Name

6 lead patient unit for NM700BT system. Includes detachable 4 lead cable.

Version/Model Number

ECGBT2

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

-

Product Code

MWI

Product Code Name

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Public Device Record Key

3793c008-124f-46dc-ad07-4b479301e3b6

Public Version Date

September 30, 2019

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

07290110251185

Quantity per Package

1

Contains DI Package

07290110252960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box