Duns Number:246848147
Device Description: Pediatric Capnoxygen Mask with 14ft oxygen tubing
Catalog Number
CO2-04-14
Brand Name
Capnoxygen®
Version/Model Number
CO2-04-14
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K971229,K971229
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
9ba59be6-eb46-422e-8276-fd77e70c65d6
Public Version Date
June 06, 2022
Public Version Number
5
DI Record Publish Date
September 01, 2016
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 | 91 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 2 |