Duns Number:023904428
Device Description: CO2 Sampling Nasal Cannula ADULT, 7’ (2.1 m) O2/CO2 SAMPLING LINE WITH MALE LUER SINGLE PA CO2 Sampling Nasal Cannula ADULT, 7’ (2.1 m) O2/CO2 SAMPLING LINE WITH MALE LUER SINGLE PATIENT USE
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-0503
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
5954351a-9de7-418e-95f0-b6338b8a5e43
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
October 22, 2019
Package DI Number
00612479208759
Quantity per Package
25
Contains DI Package
00612479208742
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |