Duns Number:504406273
Device Description: 10ft Combined O2 Delivery/CO2 Monitoring Nose Clip Filter with Microstream Type Luer
Catalog Number
-
Brand Name
Dual Adult Mask
Version/Model Number
032-10-191U
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133516
Product Code
CCK
Product Code Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Public Device Record Key
de179a04-ef2b-4ee2-9cf7-9ae0e074c844
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
December 11, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 715 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 465 |