Duns Number:079628327
Device Description: Xenon Administration Set: Air Cushion Face Mask with Injection Port, Ultra-Flex tubing (ex Xenon Administration Set: Air Cushion Face Mask with Injection Port, Ultra-Flex tubing (extends 6-24 inches), Bacterial/Viral Filter and 22 mm Adapter
Catalog Number
-
Brand Name
Xenon Master Administration Set
Version/Model Number
MN3034-IP
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
1d0f4f37-ae63-49c7-b69a-c3e2c2d20744
Public Version Date
April 26, 2022
Public Version Number
1
DI Record Publish Date
April 18, 2022
Package DI Number
00850022357619
Quantity per Package
20
Contains DI Package
00850022357602
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |