Catalog Number

455929

Brand Name

Home Monitoring Service Center

Version/Model Number

3.49

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 28, 2021

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

P950037

Product Code

OSR

Product Code Name

Pacemaker/icd/crt non-implanted components

Public Device Record Key

8ee38265-4c7e-47ef-8a4b-57b2bab2a64b

Public Version Date

July 01, 2021

Public Version Number

2

DI Record Publish Date

September 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-