Catalog Number

A10-1200-03

Brand Name

Electrodes, Holter, Button, 40 per Box, MP2E-40

Version/Model Number

Model 1200

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

K131190

Product Code

DSH

Product Code Name

RECORDER, MAGNETIC TAPE, MEDICAL

Public Device Record Key

a736c9e4-f9eb-48bb-8d69-9b47900a9fd4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-