Duns Number:079628327
Device Description: Xenon/Master Patient Delivery System. (For Xenon Gas Delivery). Mobile Cabinet type constr Xenon/Master Patient Delivery System. (For Xenon Gas Delivery). Mobile Cabinet type constructed of wood and almond color formica with leaded areas for Xenon Delivery. Includes one charcoal activated trap and has extra space for one additional activated trap (optional) for high use facilities, swivel casters with front brakes. Xenon accessory samples included.
Catalog Number
-
Brand Name
Xenon Master
Version/Model Number
XE-102
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
K810819
Product Code
IYT
Product Code Name
System, Rebreathing, Radionuclide
Public Device Record Key
08f0a865-788a-4fba-89fe-b368461e852a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 09, 2017
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |