THD Anopress - THD Anopress is a portable system that allows the - THD SPA

Duns Number:338430324

Device Description: THD Anopress is a portable system that allows the execution of the anal manometry in an ea THD Anopress is a portable system that allows the execution of the anal manometry in an easy and standardized way, by measuring the pressure data of the sphincterial cylinder in different phases: rest, squeeze, strain and endurance. THD Anopris practical and easy to use, compact, light and easily transportable. It is suitable for immediate use both in outpatient clinic and hospital. It is provided with a 3.5" color display that allows to visualize both the pressure values and the relevant curves. THD Anopress is operated by rechargeable batteries whose charge lasts approximately 5 hours. Through the Bluetooth connection, THD Anopress is able to register the exam over a dedicated software.

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More Product Details

Catalog Number

800160

Brand Name

THD Anopress

Version/Model Number

THD Anopress

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161785

Product Code Details

Product Code

KLA

Product Code Name

Monitor, Esophageal Motility, And Tube

Device Record Status

Public Device Record Key

0afbed40-5fd8-46cf-af01-254f6417ab65

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

April 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THD SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 53