Duns Number:926603486
Device Description: A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs.
Catalog Number
DU1090
Brand Name
ETCO2 Nasal Cannula
Version/Model Number
1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
a840809d-0ecc-41ac-9ba6-fcbf73d2a037
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
August 13, 2020
Package DI Number
20850014433219
Quantity per Package
100
Contains DI Package
00850014433215
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |