Catalog Number

-

Brand Name

HEPA-CARE®

Version/Model Number

HC500FD

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

K984116

Product Code

FRF

Product Code Name

Cleaner, Air, Medical Recirculating

Public Device Record Key

3695cf18-1f0d-43dd-8e88-62f3d094761a

Public Version Date

February 06, 2020

Public Version Number

1

DI Record Publish Date

January 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-