Catalog Number

BC1040A

Brand Name

INSPIRA AIR

Version/Model Number

BC1040A

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

Yes

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

K090660,K090660

Product Code

KTI

Product Code Name

BRONCHOSCOPE ACCESSORY

Public Device Record Key

24b0bd22-940c-48cb-b61c-d1061ceb953f

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

20705031063294

Quantity per Package

5

Contains DI Package

10705031063297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX