Heidelberg pH Capsule System

Basic Information

• Brand Name: Heidelberg pH Capsule System
• Primary DI: B989HPHDS180
• Version / Model: Heidelberg pH Capsule System
• Catalog Number: HPHDS18
• Company Name: Heidelberg Medical Inc
• Labeler DUNS: 023287700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-13
• Public Version: 1
• Public Version Date: 2020-11-23
• Public Version Status: New
• Public Device Record Key: a97b2fed-6f50-47e9-827a-101eb9392e3a

Device Description

The Heidelberg pH Capsule system is an assembly of devices designed to continuously monitor, measures and transmit information from the gastric and gastrointestinal systems. The transmitted gastric and gastrointestinal parameters from the pH Capsule are (i.e., pH or events), (e.g., gastric bleeding). The information from the pH capsule is received by the transceiver and then sent through the interface and to the computer. The computer software analyzes the information and displays it on a generated graph. The system assembly includes various solutions, test tubes, fluid containers and pH capsule calibration test fixture. The Heidelberg pH Capsule System is intended to help diagnose varies gastric and gastrointestinal pH related disorders.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFT	Electrode, Ph, Stomach	Gastroenterology, Urology	876.1400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58357	Gastrointestinal telemetric monitoring system	An assembly of devices designed to continuously measure and transmit signals for one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from a patient to a receiving location for viewing. It consists of a battery-powered capsule swallowed by the patient, and a patient-worn or clinician-held unit designed to wirelessly receive data from the capsule to either transmit it (i.e., a transceiver) to a computing device or to display it (e.g., a receiver); various solutions/containers may also be included. It is intended to help diagnose gastric pH disorders and/or measure gastrointestinal transit times to evaluate motility disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B989HPHDS180	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]