Address:110 Sweetgum Ln.,Mineral Bluff,GA,30559,US
Device Description : The cart (trolley) is a Non-Metallic 3 shelf mobile equipment cart, is used for The cart (trolley) is a Non-Metallic 3 shelf mobile equipment cart, is used for transporting the Heidelberg pH Capsule systems devices.
Device Class : 1
Duns Number: 023287700
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Heidelberg pH capsule system software package intended to add image processi 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 Class : 1
Duns Number: 023287700
Premarket Exempt : Yes
Prescription Use : No
Device Description : The interface module is a stationary electronic component of the Heidelberg pH c 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 Class : 1
Duns Number: 023287700
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Medallion Transceiver is a battery powered device of the Heidelberg pH Capsu 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 Class : 1
Duns Number: 023287700
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Heidelberg pH Capsule system is an assembly of devices designed to continuou 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 Class : 1
Duns Number: 023287700
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The capsule is a physiologic battery-powered device used for gastric monitoring The capsule is a physiologic battery-powered device used for gastric monitoring and data collection. The tethered pH capsule is swallowed by the patient. The information gathered by the capsule contains one or more gastric parameters (i.e., pH, events and or gastric bleeding, delayed stomach emptying, or gastric dumping). The capsule is comprised of a sensor for monitoring gastric pH and movement. The telemetric signals produced by the pH capsule are detected by the patient worn transceiver. The capsules data is transmitted from the transceiver to the Heidelberg Interface module. The interface module sends the capsule information to the computer. The computer software interprets the capsule data and displays it on computer generated graph. This is a single-use device.
Device Class : 1
Duns Number: 023287700
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The pH Capsule Calibration Kit is designed primarily for activating and calibrat 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 Class : 1
Duns Number: 023287700
Premarket Exempt : Yes
Prescription Use : Yes