Duns Number:071595540
Device Description: HarmonyAIR Smoke Evacuator Tubing
Catalog Number
QS0026
Brand Name
NA
Version/Model Number
QS0026
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 23, 2021
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
GAZ
Product Code Name
TUBING, NONINVASIVE
Public Device Record Key
aaa1bfc4-8bea-456d-a699-30e0940876c6
Public Version Date
February 23, 2021
Public Version Number
2
DI Record Publish Date
September 10, 2020
Package DI Number
30845854061880
Quantity per Package
12
Contains DI Package
20845854061883
Package Discontinue Date
February 23, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |