Duns Number:080456871
Device Description: LVN Kit, Face Tent Mask with 6’Corrugated Tube
Catalog Number
RES441676D
Brand Name
AirLife™
Version/Model Number
RES441676D
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
01c6739d-4505-4975-ac82-5283f46c0041
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 19, 2021
Package DI Number
50190752158489
Quantity per Package
10
Contains DI Package
10190752158481
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 |