Heidelberg pH Capsule System

Basic Information

• Brand Name: Heidelberg pH Capsule System
• Primary DI: B989HMI1180
• Version / Model: Heidelberg Interface Module
• Catalog Number: HMI118
• 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: 94a592b4-1624-4eb3-aa78-288ac670af29

Device Description

The interface module is a stationary electronic component of the Heidelberg pH capsule telemetric monitoring system designed to continuously monitor incoming date from the Heidelberg transceiver. The interface transmits the incoming pH data and events from the transceiver and assigns a specific channel to the data and routes it to the computer for display on one to eight graphs.

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
62386	Gastrointestinal telemetric monitoring system receiver	A portable, hand-held, electronic component of a gastrointestinal telemetric monitoring system designed 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). It may incorporate a display or be connected to an off-the-shelf device (e.g., computer, printer) to display/print the acquired data; it may also have data recording/storage capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B989HMI1180	HIBCC

Customer Contacts

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