Catalog Number

-

Brand Name

Airtime HEPA Filter Assembly Set, .010 micron

Version/Model Number

FLT-A50

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JRJ

Product Code Name

Unit, Drying

Public Device Record Key

2fb3c1de-18a9-4d29-81e8-50f5ddb2d4f0

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

December 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-