Catalog Number

-

Brand Name

Aerobiotix

Version/Model Number

AeroCure-MD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K203189

Product Code

FRA

Product Code Name

Purifier, Air, Ultraviolet, Medical

Public Device Record Key

4c6ffe64-2839-4fdd-bfb2-94b68fa1ff3d

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-