Catalog Number

-

Brand Name

AEROBIKA OPEP with Manometer

Version/Model Number

110504

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"

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

K150173,K150173,K150173

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

400ebfe9-5a91-4fbf-b8ea-20bb60a4288b

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

February 18, 2020

Package DI Number

10762860105048

Quantity per Package

10

Contains DI Package

00762860105041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-