Duns Number:022721133
Device Description: Utopia NE Full Face Mask - SM (with Black Headgear), pack of 5
Catalog Number
UTO271A
Brand Name
N/A
Version/Model Number
UTO271A
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
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
K062019,K062019
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
e8cb42f9-ed12-43fd-90a1-aed2ecd0a850
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 03, 2017
Package DI Number
10607411945714
Quantity per Package
15
Contains DI Package
00607411945717
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |