Duns Number:927071162
Device Description: EQM-U : EvaQMax Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit // Reus EQM-U : EvaQMax Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit // Reusable
Catalog Number
EQM-U
Brand Name
MediMax Tech
Version/Model Number
EvaQMax
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
K192035
Product Code
FYD
Product Code Name
Apparatus, Exhaust, Surgical
Public Device Record Key
9d3c595e-2004-4b7a-97e5-4c68309cefa9
Public Version Date
July 28, 2020
Public Version Number
4
DI Record Publish Date
April 04, 2019
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |