Duns Number:080456871
Device Description: AirLife™ Mouthpiece, small 22 mm ID
Catalog Number
132410
Brand Name
AirLife™
Version/Model Number
132410
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
BYP
Product Code Name
MOUTHPIECE, BREATHING
Public Device Record Key
f0546264-f026-4e4b-a83e-f961aabf8ad5
Public Version Date
October 21, 2020
Public Version Number
2
DI Record Publish Date
January 15, 2020
Package DI Number
50190752144543
Quantity per Package
500
Contains DI Package
10190752144545
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 |