Duns Number:036985604
Device Description: The HarmonyAIR Smoke Evacuator Remote Switch Activator (RSA) is used with the HarmonyAIR S The HarmonyAIR Smoke Evacuator Remote Switch Activator (RSA) is used with the HarmonyAIR Smoke Evacuation System.
Catalog Number
QS0028
Brand Name
HarmonyAIR
Version/Model Number
Smoke Evacuator Remote Switch Activator
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
-
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
FYD
Product Code Name
APPARATUS, EXHAUST, SURGICAL
Public Device Record Key
f6fabbb8-cb24-4596-93e4-6ed3241c8bd0
Public Version Date
December 22, 2020
Public Version Number
7
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 |