Duns Number:036985604
Device Description: The HarmonyAIR Smoke Evacuator Filter Fluid Traps is a box of 10 filter fluid traps for th The HarmonyAIR Smoke Evacuator Filter Fluid Traps is a box of 10 filter fluid traps for the HarmonyAIR Smoke Evacuator that is designed to capture fluids to help maintain the integrity of the filtration system and assist with maintaining filter life.
Catalog Number
QS0027
Brand Name
HarmonyAIR
Version/Model Number
Smoke Evacuator Filter Fluid Trap
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 22, 2020
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAZ
Product Code Name
TUBING, NONINVASIVE
Public Device Record Key
84810f36-ad9c-4e34-b63c-4277cc76cd10
Public Version Date
January 27, 2021
Public Version Number
10
DI Record Publish Date
September 06, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |