Catalog Number

-

Brand Name

microlife

Version/Model Number

BP3GY1-2N

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

658df6a6-744a-4fbd-bf9a-82de87f2c7b0

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

April 10, 2019

Package DI Number

20642632900019

Quantity per Package

6

Contains DI Package

10642632900012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-