Catalog Number

-

Brand Name

AIM

Version/Model Number

4500

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

K893665,K893665

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Public Device Record Key

fa92b5a3-0fb7-409c-a903-7ed188bb8d4b

Public Version Date

December 28, 2021

Public Version Number

1

DI Record Publish Date

December 20, 2021

Package DI Number

05099169331884

Quantity per Package

1

Contains DI Package

15099169331881

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-