Duns Number:092673953
Device Description: Adult nasal Cannula, 10' O2/CO2 Sampling Line w/female Luer
Catalog Number
-
Brand Name
Comfort Soft Plus CO2 Sampling Nasal Cannula
Version/Model Number
0539
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
d6fe1d3e-7ed2-45e6-9ca2-0bdea74a2b7d
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
November 24, 2016
Package DI Number
10709078001427
Quantity per Package
25
Contains DI Package
00709078001420
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 |