Catalog Number

-

Brand Name

Balance

Version/Model Number

0605

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

K122482,K122482

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

8d95d943-368f-4aa1-858a-d4db555a6c0a

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10875011006054

Quantity per Package

24

Contains DI Package

00875011006057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton