Catalog Number

UTO271A

Brand Name

Utopia NE

Version/Model Number

SM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

328974c6-3e59-4090-8cd1-6369d32e91a8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Package DI Number

M694UTO271A5

Quantity per Package

3

Contains DI Package

M694UTO271A3

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton