Catalog Number

1474

Brand Name

Aerosure

Version/Model Number

3481AJ

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

K140772,K140772

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

046b462f-0cbb-49c6-a429-c8a44daaffdf

Public Version Date

May 12, 2021

Public Version Number

1

DI Record Publish Date

May 04, 2021

Package DI Number

10858058005044

Quantity per Package

10

Contains DI Package

00858058005047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton