Duns Number:830432451
Device Description: Airlife™ Universal IPPB Manifold and Nebulizer (Quick-Neb) With 39" (99 cm), 22 mm I Airlife™ Universal IPPB Manifold and Nebulizer (Quick-Neb) With 39" (99 cm), 22 mm ID Corrugated Tubing, Two Supply Lines, Mouthpiece and 6" (15 cm), 22 mm ID Flextube
Catalog Number
001618
Brand Name
AirLife
Version/Model Number
001618
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
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
ec49b9d3-a704-410b-873a-c7da8f561632
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
50885403011724
Quantity per Package
50
Contains DI Package
10885403011726
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 |