Duns Number:022721133
Device Description: Adult. EtCO2/O2 Nasal Divided Cannula, female thread grip O2 connector and male luer style Adult. EtCO2/O2 Nasal Divided Cannula, female thread grip O2 connector and male luer style CO2 connector.
Catalog Number
4707TG-7-7
Brand Name
N/A
Version/Model Number
4707TG-7-7
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
c577487a-0871-4755-921b-8520241064a9
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
July 20, 2018
Package DI Number
10607411961370
Quantity per Package
25
Contains DI Package
00607411961373
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 |