Duns Number:092673953
Device Description: Adult Nasal Cannula, 10" O2/CO2 Sampling Line w/ Male Luer
Catalog Number
-
Brand Name
CO2 Sampling Nasal Cannula
Version/Model Number
B180030C
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
-
Product Code
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
cd7fa9dd-ef8a-47c5-aadd-adeaab758ce9
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
December 22, 2017
Package DI Number
10709078004381
Quantity per Package
100
Contains DI Package
00709078004384
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 | 746 |
2 | A medical device with a moderate to high risk that requires special controls. | 320 |