Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

BP3600

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

f7beccbf-be60-4a73-9102-c84309b5c0c5

Public Version Date

July 16, 2019

Public Version Number

3

DI Record Publish Date

November 01, 2016

Package DI Number

50822383584251

Quantity per Package

24

Contains DI Package

00822383584256

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-