Duns Number:262972663
Device Description: PlasmaTYPHOON - unit for fast drying of endoscope channels and active storage of endoscope PlasmaTYPHOON - unit for fast drying of endoscope channels and active storage of endoscopes Voltage: 100-120 VACFrequency: 50/60 HzElectric plug: Type B (USA, CA, JP, MX)
Catalog Number
-
Brand Name
PlasmaTYPHOON
Version/Model Number
Typhoon-V2TD120
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXG
Product Code Name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Public Device Record Key
3f576642-e5d3-438c-99d5-9cb862897a36
Public Version Date
May 20, 2021
Public Version Number
1
DI Record Publish Date
May 12, 2021
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 | 82 |