Heidelberg pH Capsule System

Basic Information

• Brand Name: Heidelberg pH Capsule System
• Primary DI: B989HMT00180
• Version / Model: Heidelberg Medallion Transceiver
• Catalog Number: HMT0018
• 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: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 4462c0a9-9108-4b78-a4b0-800b7e65d33c

Device Description

The Medallion Transceiver is a battery powered device of the Heidelberg pH Capsule system, designed to be worn by the patient. The transceiver continuously monitors and transmits information from the Heidelberg pH capsule. The transceiver’s internal firmware also monitors the pH capsule’s strength in real time, calibration accuracy and pH levels. The pH capsule’s information received by the transceiver is sent by telemetry to the Heidelberg interface module. The Interface module forwards the Medallion Transceiver’s information to the computer for display.

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
60357	Gastrointestinal telemetric monitoring system transceiver	A battery-powered component of a gastrointestinal telemetric monitoring system designed to be worn by a patient to continuously and wirelessly receive electrical signals of gastrointestinal parameters (e.g., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from an ingested capsule (not included), and transmit the signals to an appropriate device (e.g., computer, monitor) for further processing and/or display. It may have data recording/storage capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B989HMT00180	HIBCC

Customer Contacts

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