Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

T816-30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

K020003,K020003,K020003

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

8b3923e1-0bf3-46d8-913a-5870eb16a018

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 29, 2016

Package DI Number

20817120020184

Quantity per Package

20

Contains DI Package

00817120020180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box