Duns Number:078863378
Device Description: Venue Fit R4 MD either eDelivery or physical
Catalog Number
-
Brand Name
Venue Fit
Version/Model Number
R4 UPG
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
K220848
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
ed798675-e58d-4119-b661-dfd2adf0c77f
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 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. | 34 |
3 | A medical device with high risk that requires premarket approval | 5 |