Duns Number:022721133
Device Description: Adult. EtCO2/O2 Nasal Divided Cannula, female threadgrip CO2 connector. Adaptor 22 mm (ID) Adult. EtCO2/O2 Nasal Divided Cannula, female threadgrip CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD)
Catalog Number
47SOFT-FTG-7-0
Brand Name
N/A
Version/Model Number
47SOFT-FTG-7-0
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
-
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
8d156033-92fb-4c15-a82e-c3253d9c3125
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
October 26, 2017
Package DI Number
10607411946742
Quantity per Package
25
Contains DI Package
00607411946745
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 |