Duns Number:043833813
Device Description: KIT, XENON CONVENIENCE, FACE MASK WITH INJECTION PORT, INCLUDES BACTERIA FILTER AND ULTRA- KIT, XENON CONVENIENCE, FACE MASK WITH INJECTION PORT, INCLUDES BACTERIA FILTER AND ULTRA-FLEX TUBING
Catalog Number
132-691
Brand Name
Xenon Rebreathing System
Version/Model Number
132-691
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
549788a6-90cc-4f04-823c-bb8b764125c8
Public Version Date
October 24, 2019
Public Version Number
1
DI Record Publish Date
October 16, 2019
Package DI Number
10718175005054
Quantity per Package
25
Contains DI Package
00718175005057
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 |