Catalog Number

-

Brand Name

BIOFLUX

Version/Model Number

1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K172311,K172311,K172311,K172311,K172311,K172311

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Public Device Record Key

4e902b39-b065-4703-92cf-59861d26300a

Public Version Date

May 07, 2019

Public Version Number

3

DI Record Publish Date

May 02, 2018

Package DI Number

B635BIOFLUX101

Quantity per Package

5

Contains DI Package

B635BIOFLUX100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-