Duns Number:551540334
Device Description: Set consisting of:P/N 101249 Carrying Bag QScreenP/N 101199 QScreenP/N 101253 Docking Stat Set consisting of:P/N 101249 Carrying Bag QScreenP/N 101199 QScreenP/N 101253 Docking Station QScreenP/N 101315-E QScreen Check KitP/N 101250-12W Power Supply or P/N 101250-12W-NEO Power SupplyP/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual englishP/N 101334 Flyer QScreen
Catalog Number
-
Brand Name
QScreen Set
Version/Model Number
101275
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
K220139
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
ec4ab4f8-5d6a-4c27-931d-95a7c378cf7a
Public Version Date
August 22, 2022
Public Version Number
1
DI Record Publish Date
August 12, 2022
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |