Catalog Number

-

Brand Name

Balance

Version/Model Number

0607

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

35429e9f-f686-4318-8898-fa0b1c66821b

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

September 17, 2018

Package DI Number

10875011006078

Quantity per Package

24

Contains DI Package

00875011006071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton