Catalog Number

-

Brand Name

BodyGuardian

Version/Model Number

EUBG2012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 24, 2021

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"

Yes

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

33c66094-ad84-409c-aa7c-9e35522cf82d

Public Version Date

June 17, 2021

Public Version Number

2

DI Record Publish Date

August 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-