Catalog Number

-

Brand Name

BodyGuardian Mini Plus Monitoring System Kit

Version/Model Number

BG2104

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Public Device Record Key

e0e16c0a-fe7c-430e-ba44-a4c225c88864

Public Version Date

April 05, 2022

Public Version Number

2

DI Record Publish Date

June 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-