Duns Number:043833813
Device Description: Disposable Xenon-133 Rebreathing System
Catalog Number
060-133
Brand Name
Xenon Rebreathing System
Version/Model Number
060-133
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
Yes
Prescription Use (Rx)
-
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
1c9ac367-e563-499f-b044-794acc156f56
Public Version Date
September 06, 2018
Public Version Number
3
DI Record Publish Date
December 18, 2017
Package DI Number
30718175001364
Quantity per Package
15
Contains DI Package
00718175001332
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 193 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |