Duns Number:022721133
Device Description: CapnoVue M1 Mask (Adult). Single patient use.
Catalog Number
4737-14-0
Brand Name
CapnuVue
Version/Model Number
4737-14-0
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
K151421,K151421
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
3578057f-7aa3-480f-a02e-ed94c7f05672
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
January 27, 2020
Package DI Number
10607411971348
Quantity per Package
50
Contains DI Package
00607411971341
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 |