Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

BP2000

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

4a42d172-491e-4ee7-9635-181efcdd0a7f

Public Version Date

July 16, 2019

Public Version Number

3

DI Record Publish Date

July 01, 2016

Package DI Number

50822383537622

Quantity per Package

100

Contains DI Package

00822383537627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-