Duns Number:927071162
Device Description: EQM-CAF : EvaQMax Filter for the EvaQMax Unit / each/ reusable
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
EQM-CAF
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
-
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,K192035
Product Code
FYD
Product Code Name
Apparatus, Exhaust, Surgical
Public Device Record Key
0038834d-eaca-4e2d-879a-f5743bb02785
Public Version Date
September 11, 2019
Public Version Number
1
DI Record Publish Date
September 03, 2019
Package DI Number
10817325023570
Quantity per Package
4
Contains DI Package
00817325023573
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box
| 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 |