Duns Number:092673953
Device Description: Adult nasal Cannula w/ 21' O2/CO2 sampling line w/ male luer
Catalog Number
-
Brand Name
CO2 Sampling Nasal Cannula
Version/Model Number
0541
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
CCK
Product Code Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Public Device Record Key
7d663d7f-aa7f-4f43-abe3-4090e762d1e4
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
May 17, 2018
Package DI Number
10709078005678
Quantity per Package
25
Contains DI Package
00709078005671
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 |