Catalog Number

-

Brand Name

HEPA-CARE®

Version/Model Number

HC400FD

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

ae4a879b-f1a6-488b-b6d6-36ffdb4d8030

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-