Duns Number:036985604
Device Description: The HarmonyAIR Sterile Smoke Evacuator Tubing, 7/8 inch x 10 Foot sterile tubing, is used The HarmonyAIR Sterile Smoke Evacuator Tubing, 7/8 inch x 10 Foot sterile tubing, is used for the HarmonyAIR Smoke Evacuator.
Catalog Number
QS0024
Brand Name
HarmonyAIR
Version/Model Number
Smoke Evacuator Tubing
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
2086a579-f772-4520-b56d-df69c497e75c
Public Version Date
January 27, 2021
Public Version Number
7
DI Record Publish Date
September 06, 2016
Package DI Number
50724995150087
Quantity per Package
24
Contains DI Package
00724995150082
Package Discontinue Date
December 22, 2020
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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |