Duns Number:368457563
Device Description: HEPA Filter Hydrophobic Pleated Bacterial/ Viral Filter with Gas Sampling Port, Disposable
Catalog Number
-
Brand Name
AirLife™
Version/Model Number
M1043237
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
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
fc830952-c268-44d9-ad35-3f4102e3e9f5
Public Version Date
September 22, 2020
Public Version Number
2
DI Record Publish Date
September 01, 2019
Package DI Number
20190752146720
Quantity per Package
50
Contains DI Package
10190752146723
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |