Catalog Number

-

Brand Name

ULPA Filter & Water Trap

Version/Model Number

ICM-000-0307

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

6d11e017-4396-410d-bbe7-c4d6a4c9e12f

Public Version Date

April 08, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00817688021469

Quantity per Package

25

Contains DI Package

00817688021452

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-