Catalog Number

BIOMODULE HOLDER

Brand Name

Zephyr

Version/Model Number

BIOMODULE HOLDER

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

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

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

e6d9e614-e962-4747-a8af-6885cf96523d

Public Version Date

May 25, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10884521713574

Quantity per Package

99

Contains DI Package

10884521706026

Package Discontinue Date

March 26, 2018

Package Status

Not in Commercial Distribution

Package Type

CASE