Duns Number:079628327
Device Description: Mouthpiece, Rigid w/Injection Port & Bacteria Filter, Flexible Tubing, Ventilator Circuit
Catalog Number
-
Brand Name
Xenon Master Administration Set
Version/Model Number
MN1212
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
ca07ae26-fcf4-4016-830b-589f0c0d2c34
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
June 09, 2017
Package DI Number
00857863007536
Quantity per Package
20
Contains DI Package
00857863007451
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 |