Catalog Number

001-400-0122

Brand Name

GI Holter System

Version/Model Number

M12R

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

K051730

Product Code

MLO

Product Code Name

Electrocardiograph, Ambulatory, With Analysis Algorithm

Public Device Record Key

0068236d-d13e-4740-902d-f5ff17068ccc

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

October 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-