Duns Number:092673953
Device Description: Hepa Filter, W/CO2 Port and Elbow
Catalog Number
-
Brand Name
Filter
Version/Model Number
6145
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
MOD
Product Code Name
Accessory To Continuous Ventilator (Respirator)
Public Device Record Key
58e1ad46-5a5b-4752-862c-e8fe0fdf63e9
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
December 23, 2016
Package DI Number
10709078000987
Quantity per Package
50
Contains DI Package
00709078000980
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |