Duns Number:080456871
Device Description: AirLife™ Hygroscopic Condenser Humidfier
Catalog Number
5708HEPA
Brand Name
AirLife™
Version/Model Number
5708HEPA
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"
-
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
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
bbcad5c5-74ea-41e9-b51f-603d646111cb
Public Version Date
February 12, 2020
Public Version Number
1
DI Record Publish Date
February 04, 2020
Package DI Number
50190752147179
Quantity per Package
50
Contains DI Package
10190752147171
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 |