Catalog Number

453795

Brand Name

Home Monitoring Service Center

Version/Model Number

3.48

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 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

-

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

9caa1926-a927-4278-a0c4-cf64a5283499

Public Version Date

October 19, 2020

Public Version Number

2

DI Record Publish Date

May 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-