Duns Number:600023576
Device Description: Roll Stand for use with F60 and Ventoux ventilators
Catalog Number
-
Brand Name
Roll Stand for use with ventilators
Version/Model Number
MEB-0097
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
cdd99142-9ac8-4e97-bab0-9caba85b882d
Public Version Date
September 14, 2022
Public Version Number
1
DI Record Publish Date
September 06, 2022
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 46 |