Catalog Number

-

Brand Name

Balance

Version/Model Number

0608

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

K090014,K090014

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

f2df44a2-cc31-4361-9dbf-56ce1e08a576

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 29, 2017

Package DI Number

10875011006085

Quantity per Package

25

Contains DI Package

00875011006088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-