Catalog Number

1005-01

Brand Name

Lung Flute® Therapeutic

Version/Model Number

1005-01

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091557,K091557

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

1ad1bdbb-7085-4cf5-8104-9ccf801235fb

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

January 31, 2017

Package DI Number

20816133010083

Quantity per Package

50

Contains DI Package

00816133010089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case