Duns Number:092673953
Device Description: CO2 Sampling Nasal Cannula, 15"
Catalog Number
-
Brand Name
Cannula
Version/Model Number
2100-W
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
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
4e2d3764-d896-4c40-ba40-9c0a3b2dff28
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
October 30, 2020
Package DI Number
10709078010870
Quantity per Package
50
Contains DI Package
00709078010873
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 | 746 |
2 | A medical device with a moderate to high risk that requires special controls. | 320 |