Catalog Number

PMDBPA

Brand Name

Protekt Blood Pressure Monitor, Digital, Auto Inflate w/ Batteries

Version/Model Number

PMDBPA

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150545,K150545

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

96e2ea9b-8c5d-4eae-be94-c1a4ce4a7480

Public Version Date

January 09, 2020

Public Version Number

1

DI Record Publish Date

January 01, 2020

Package DI Number

05060488571015

Quantity per Package

24

Contains DI Package

05060488570933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton