Catalog Number

BH3-M2

Brand Name

Zephyr

Version/Model Number

BH3-M2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 26, 2018

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

-

Product Code

MHX

Product Code Name

MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Public Device Record Key

cb53e50d-55d5-488b-bb99-9b3798ec415f

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

January 24, 2018

Package DI Number

90884521725467

Quantity per Package

999

Contains DI Package

10884521725461

Package Discontinue Date

March 26, 2018

Package Status

Not in Commercial Distribution

Package Type

CASE