Catalog Number

-

Brand Name

Aerobiotix

Version/Model Number

AeroCure Vac HEPA Filter Assembly

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

-

Product Code

FRA

Product Code Name

Purifier, Air, Ultraviolet, Medical

Public Device Record Key

90c39550-9392-4173-9c09-c1191e80f156

Public Version Date

January 13, 2022

Public Version Number

2

DI Record Publish Date

December 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-