Duns Number:243872611
Device Description: Customized Single-Use Barostat Catheter (with 150mL Balloon)
Catalog Number
-
Brand Name
Mui Scientific
Version/Model Number
S7-BR-1033
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K973844,K973844
Product Code
FFX
Product Code Name
System, Gastrointestinal Motility (Electrical)
Public Device Record Key
fb5b2f70-8c6d-452e-804d-2bb2cdd5ed14
Public Version Date
August 19, 2022
Public Version Number
1
DI Record Publish Date
August 11, 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 |
---|---|---|
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. | 963 |