Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

BP2116

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

d4b5e8f3-7005-49e3-aaf1-e3f96e5c9f07

Public Version Date

July 16, 2019

Public Version Number

3

DI Record Publish Date

July 01, 2016

Package DI Number

50822383567315

Quantity per Package

24

Contains DI Package

00822383567310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-