Duns Number:458942687
Device Description: The Sigma Delta MRI vaporizer is designed for incorporation in the fresh gas supply system The Sigma Delta MRI vaporizer is designed for incorporation in the fresh gas supply system of continuous flow anaesthetic machines, directly connected between the flowmeter unit and the common gas outlet of the machine.Its purpose is the provision of accurate concentrations of the anaesthetic drugs into the fresh gas supply, according to the setting of the control dial.The Sigma Delta MRI vaporizer can be used within an MRI environment with both 1.5T and 3T magnets and for anaesthetic drugs Isoflurane, Enflurane, Sevoflurane and Halothane.
Catalog Number
-
Brand Name
Penlon
Version/Model Number
Sigma Delta MRI
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
K002343
Product Code
CAD
Product Code Name
Vaporizer, Anesthesia, Non-Heated
Public Device Record Key
a9b3076b-7a94-4a92-8f93-f925adaf6451
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 18, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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. | 37 |