Duns Number:830432451
Device Description: Vital Signs™ Xenon Breathing Circuit Non-Conductive
Catalog Number
9500X
Brand Name
Vital Signs
Version/Model Number
9500X
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
-
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
4fe68aaa-5b03-43aa-aafc-21690f8fdcbe
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
50885403296725
Quantity per Package
10
Contains DI Package
10885403296727
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |