Catalog Number

ICM-000-0420

Brand Name

ULPA Filter & Water Trap

Version/Model Number

2210

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

-

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

3fa25f25-b06e-4168-8ccb-a6f750b742b9

Public Version Date

April 08, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00817688021483

Quantity per Package

9

Contains DI Package

00817688021476

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-