Duns Number:078731530
Device Description: Adult Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring (Male to F Adult Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring (Male to Female)
Catalog Number
-
Brand Name
POM Elite MF
Version/Model Number
1001-MF
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"
-
For Single-Use
-
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
K172365,K172365
Product Code
CCK
Product Code Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Public Device Record Key
90dd39ed-a91a-42fc-9b44-c81f876e6809
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 11, 2018
Package DI Number
20851438008038
Quantity per Package
30
Contains DI Package
10851438008031
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |