Catalog Number

-

Brand Name

BodyGuardian

Version/Model Number

SB1002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 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

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

-

Product Code

MLN

Product Code Name

Electrode, Electrodcardiograph, Multi-Function

Public Device Record Key

4f12f7e1-ec65-4de6-b0da-580136a0ea40

Public Version Date

November 02, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-