Duns Number:830432451
Device Description: AirLife CPAP Mask
Catalog Number
9000C5
Brand Name
AirLife
Version/Model Number
9000C5
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
BYE
Product Code Name
Attachment, Breathing, Positive End Expiratory Pressure
Public Device Record Key
a512b818-2243-4d18-b78d-ce222d73f45d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 29, 2016
Package DI Number
50885403296268
Quantity per Package
10
Contains DI Package
10885403296260
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| 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 |