Catalog Number

04-635-001

Brand Name

HealthSmart

Version/Model Number

04-635-001

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)

-

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

2757d3d6-74ed-46ba-8074-759aac6ef865

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10767056635019

Quantity per Package

4

Contains DI Package

30767056635013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton