Duns Number:080456871
Device Description: AirLife™ Corrugated Flexible Polyethylene and EVA Tubing Segmented 100 foot (30.5 m) Roll AirLife™ Corrugated Flexible Polyethylene and EVA Tubing Segmented 100 foot (30.5 m) Roll for Aerosol and IPPB Use
Catalog Number
001426
Brand Name
AirLife™
Version/Model Number
001426
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
-
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
5f43ff74-f21a-4608-8b47-62a46ffc7308
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
February 21, 2020
Package DI Number
50190752116809
Quantity per Package
1
Contains DI Package
10190752116801
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 | 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 |