Catalog Number

731-9159

Brand Name

AeroNOx 2.0 Nitric Oxide Delivery Device

Version/Model Number

AeroNOx 2.0

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

K193481

Product Code

MRN

Product Code Name

Apparatus, Nitric Oxide Delivery

Public Device Record Key

e9714642-5940-4ce2-adf9-b02b4d58f56d

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-