Duns Number:830432451
Device Description: Airlife™ Face Tent Mask, 7' O2 Tube, O2 Stem with Plug Face Tent Mask, 7' O2 Tube, O Airlife™ Face Tent Mask, 7' O2 Tube, O2 Stem with Plug Face Tent Mask, 7' O2 Tube, O2 Stem with Plug 22mm OD x 18mm ID
Catalog Number
RES411956B
Brand Name
AirLife
Version/Model Number
RES411956B
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
OGL
Product Code Name
Oxygen administration kit
Public Device Record Key
9e5c53aa-ea5c-4d67-a1eb-2f7e35892f94
Public Version Date
May 23, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
50885403184299
Quantity per Package
50
Contains DI Package
10885403184291
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 |