Utopia AV - Utopia AV Full Face Mask - SM (with Black - Innomed Technologies Inc

Duns Number:103307950

Device Description: Utopia AV Full Face Mask - SM (with Black Headgear)

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More Product Details

Catalog Number

UTO251A

Brand Name

Utopia AV

Version/Model Number

UTO251A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Device Record Status

Public Device Record Key

b3ae8f61-6473-4334-ae6c-cc80e9d388be

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

50833224001028

Quantity per Package

30

Contains DI Package

00833224001023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INNOMED TECHNOLOGIES INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 74