Catalog Number

-

Brand Name

Holter Prep Kit

Version/Model Number

043272

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

K945985,K945985,K945985

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Public Device Record Key

28a983cd-0fc7-4e14-9db2-ee264ad76fa3

Public Version Date

June 29, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20812345029936

Quantity per Package

10

Contains DI Package

10812345029939

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-