Mui Scientific - Customized Barostat Balloon Replacement - H & A Mui Enterprises Inc

Duns Number:243872611

Device Description: Customized Barostat Balloon Replacement

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More Product Details

Catalog Number

-

Brand Name

Mui Scientific

Version/Model Number

CT-B-RECTANGLE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K973844

Product Code Details

Product Code

FFX

Product Code Name

System, Gastrointestinal Motility (Electrical)

Device Record Status

Public Device Record Key

6225a98e-2f75-4786-8b32-16b467725b4b

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

October 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"H & A MUI ENTERPRISES INC" Characteristics
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