Catalog Number

UTO255A

Brand Name

Utopia AV

Version/Model Number

UTO255A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

63d7ae02-5f5a-4a1b-adee-134992c42c79

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Package DI Number

50833224001042

Quantity per Package

30

Contains DI Package

00833224001047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-