Duns Number:030619483
Catalog Number
-
Brand Name
Aero-Pro HEPA Small Angled
Version/Model Number
20151
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
fc4231e4-602d-4792-a372-7a7e78efa794
Public Version Date
April 04, 2022
Public Version Number
1
DI Record Publish Date
March 25, 2022
Package DI Number
10841470110014
Quantity per Package
25
Contains DI Package
00841470110017
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 | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 491 |