Duns Number:103307950
Device Description: Utopia AV Full Face Mask - SM (with Black Headgear)
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
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
b3ae8f61-6473-4334-ae6c-cc80e9d388be
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2016
Package DI Number
50833224001028
Quantity per Package
30
Contains DI Package
00833224001023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 74 |