Duns Number:071595540
Device Description: HARMONYAIR FLUID TRAP, STERIS
Catalog Number
QS0027
Brand Name
HarmonyAIR
Version/Model Number
QS0027
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"
-
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
123bdd7d-57df-44a2-84d3-5fb071325608
Public Version Date
September 21, 2020
Public Version Number
1
DI Record Publish Date
September 11, 2020
Package DI Number
30845854081819
Quantity per Package
10
Contains DI Package
20845854081812
Package Discontinue Date
-
Package Status
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 |