Catalog Number

BFH6S-25

Brand Name

6in HEPA Capsules with Removable Stickers

Version/Model Number

BFH6S-25

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

JRL

Product Code Name

Unit, Filter, Membrane

Public Device Record Key

0fde7ddc-d9f7-4aee-8fde-c12c26d4a438

Public Version Date

August 29, 2018

Public Version Number

1

DI Record Publish Date

July 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-