Catalog Number

-

Brand Name

Holter Prep Kit

Version/Model Number

XKTHOLT5LA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 16, 2020

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

-

Product Code

MWJ

Product Code Name

Electrocardiograph,Ambulatory(Without Analysis)

Public Device Record Key

53ae5108-ee3d-42a2-81b8-d14f6f6eeaa9

Public Version Date

July 17, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

30812345026024

Quantity per Package

3

Contains DI Package

20812345026027

Package Discontinue Date

July 16, 2020

Package Status

Not in Commercial Distribution

Package Type

-