Duns Number:092673953
Device Description: Comfort Soft Plus Pediatric Nasal Cannula, 7' O2 Line, 2" CO2 Sampling Line w/Female Luer
Catalog Number
-
Brand Name
Comfort Soft Plus
Version/Model Number
0870
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
656f7f73-0834-40d4-b709-c02d3e27802d
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
September 30, 2020
Package DI Number
10709078010580
Quantity per Package
25
Contains DI Package
00709078010583
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 |