Catalog Number

P-50

Brand Name

AccuSensor

Version/Model Number

P-50

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"

-

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

2e97ea92-3dd9-4bbf-a57d-71e6c870ea05

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 09, 2016

Package DI Number

10851491007101

Quantity per Package

10

Contains DI Package

00851491007104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case