Heidelberg pH Capsule System

Basic Information

• Brand Name: Heidelberg pH Capsule System
• Primary DI: B989PCCK3300
• Version / Model: Heidelberg pH Capsule Calibration Kit
• Catalog Number: PCCK330
• 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: 96d246e2-af9c-4b9c-baeb-3ccc28f83fbc

Device Description

The pH Capsule Calibration Kit is designed primarily for activating and calibrating the pH telemetric capsule, it includes the following: the calibration test fixture is a 10-inch square acrylic plate that contains a raised capsule holder for holding the pH capsule during calibration. The acrylic plate also has a clear acrylic block attached to it, for holding 6 test tubes. There are two large round holes in the sides of the plate: for holding the Saline and Rinse contains. There is also provision for placement of the glass Alkaline challenge container. Included with the Kit is a glass container labeled Saline, a glass container labeled Rinse and a glass container labeled NaCH03. The kit contains 6 test tubes, one spool of tether thread, solutions, a 6-inch Delrin capsule holder: for holding the pH capsule during the pH calibration procedure.

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: 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
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	B989PCCK3300	HIBCC

Customer Contacts

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