Catalog Number

-

Brand Name

Electronic Blood Pressure Monitor

Version/Model Number

PG-800B8

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

K131558,K131558

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

bd2d4fd3-2c16-415b-854a-fc05c056ec57

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

November 23, 2016

Package DI Number

06948423800347

Quantity per Package

1

Contains DI Package

06948423800149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-