Duns Number:080456871
Device Description: Oxygen Catheter
Catalog Number
K20
Brand Name
AirLife™
Version/Model Number
K20
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"
-
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
OFO
Product Code Name
Airway suction kit
Public Device Record Key
0c6e7576-ec75-4044-97b0-0e9b91cd0633
Public Version Date
September 13, 2022
Public Version Number
1
DI Record Publish Date
September 05, 2022
Package DI Number
50190752117684
Quantity per Package
50
Contains DI Package
10190752117686
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 | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |