Duns Number:830432451
Device Description: Airlife™ Prefill Nebulizer Kit Nebulizer Cap and Sterile Water for Inhalation, USP, Airlife™ Prefill Nebulizer Kit Nebulizer Cap and Sterile Water for Inhalation, USP, 1000 ml
Catalog Number
CK0010
Brand Name
AirLife
Version/Model Number
CK0010
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
OGG
Product Code Name
Humidifier nebulizer kit
Public Device Record Key
e0444cc3-6cba-4abf-88ad-1951d69a8029
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
50885403164765
Quantity per Package
12
Contains DI Package
10885403221484
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |