Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

PT2334 Resting Tabs SJS

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

K040784,K040784,K040784

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

f8b3271f-8e41-4ae3-ba1b-fd821dfb5b0c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 28, 2016

Package DI Number

20817120020597

Quantity per Package

10

Contains DI Package

10817120020590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case