THD Anopress 800140

GUDID 18033737711245

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.

THD SPA

Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system

• Primary Device ID: 18033737711245
• NIH Device Record Key: 5089fa11-5805-446f-afc9-f5839224d855
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THD Anopress
• Version Model Number: THD Anopress
• Catalog Number: 800140
• Company DUNS: 338430324
• Company Name: THD SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390522634311
• Email: regulatory@thdlab.com
• Phone: +390522634311
• Email: regulatory@thdlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18033737711245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161785

FDA Product Code

• KLA: Monitor, Esophageal Motility, And Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-04-14

On-Brand Devices [THD Anopress]

• 18033737711412: THD Anopress is a portable system that allows the execution of the anal manometry in an easy and
• 18033737711245: THD Anopress is a portable system that allows the execution of the anal manometry in an easy and