Duns Number:079628327
Device Description: Xenon Administration Set: Face Mask, Air-Cushioned, Adult Size 5 & Bacteria Filter, Adapt Xenon Administration Set: Face Mask, Air-Cushioned, Adult Size 5 & Bacteria Filter, Adapter, Flexible Tubing
Catalog Number
-
Brand Name
Xenon Master Administration Set
Version/Model Number
MN3034
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"
Yes
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
-
Product Code
IYT
Product Code Name
System, Rebreathing, Radionuclide
Public Device Record Key
0e34598e-a4c0-46af-91be-ef3a94ceddf2
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
June 09, 2017
Package DI Number
00857863007529
Quantity per Package
20
Contains DI Package
00857863007444
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |