Catalog Number

11050194100

Brand Name

AEROBIKA Oscillating Positive Expiratory Pressure Therapy System

Version/Model Number

110501

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2020

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123400,K123400

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

6bf383b4-362d-47bb-8115-7bd231373f99

Public Version Date

June 22, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-