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,K893665

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Public Device Record Key

255c1260-db47-494c-b93a-1d3a717a18a4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 21, 2017

Package DI Number

35099169457332

Quantity per Package

25

Contains DI Package

05099169457331

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-