Duns Number:830432451
Device Description: AirLife® CPAP Mask
Catalog Number
9100
Brand Name
AirLife
Version/Model Number
9100
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
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
8a2aa7cc-01b4-4b37-9ee7-ca3506f7c4e4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
Package DI Number
50885403290181
Quantity per Package
10
Contains DI Package
10885403290183
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 |