Catalog Number

-

Brand Name

ULPA Box Filter

Version/Model Number

ICM-000-0460

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

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Public Device Record Key

da70fe1d-620f-47d9-8deb-7e426a1fb170

Public Version Date

April 08, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00817688021780

Quantity per Package

10

Contains DI Package

00817688021773

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-