Catalog Number

-

Brand Name

Drive

Version/Model Number

BP2610

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

1d8f6069-9ada-4321-88e8-957af05d5cd3

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

July 01, 2016

Package DI Number

10822383537631

Quantity per Package

125

Contains DI Package

00822383537634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-