Heidelberg pH Capsule System

Basic Information

• Brand Name: Heidelberg pH Capsule System
• Primary DI: B989HCNS180
• Version / Model: Heidelberg pH Capsule System Software
• Catalog Number: HCNS18
• 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: 9605b7a1-f502-4c58-bdc5-a1b20795c6d9

Device Description

The Heidelberg pH capsule system software package intended to add image processing and/or analysis capabilities to a gastric and gastrointestinal telemetric monitoring system used to help diagnose gastric pH disorders and/or measure gastric and gastrointestinal pH via wirelessly transmitted signals from a pH telemetric capsule swallowed by the patient. It may be installed in a portable hand-held receiver or in a computing device to which measured data that is transmitted by a transceiver.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
58358	Gastrointestinal telemetric monitoring system application software	A software package intended to add image processing and/or analysis capabilities to a gastrointestinal telemetric monitoring system used to help diagnose gastric pH disorders and/or measure gastrointestinal transit times via wirelessly transmitted signals from a capsule swallowed by the patient. It may be installed in a portable hand-held receiver or in a computing device to which measured data is transmitted by a transceiver.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B989HCNS180	HIBCC

Customer Contacts

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