Catalog Number

-

Brand Name

Hepa Filter

Version/Model Number

1002217

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

efb8d760-97ff-4cb9-840c-ca2392ed934d

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Package DI Number

10709078014007

Quantity per Package

50

Contains DI Package

00709078014000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-