Heidelberg pH Capsule System

Primary DI
B989HPHDS180
Brand
Heidelberg pH Capsule System
Company
Heidelberg Medical Inc
Model
Heidelberg pH Capsule System
Catalog number
HPHDS18
Device description
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.
Published
2020-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFTElectrode, Ph, Stomach

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFTElectrode, Ph, StomachGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B989HPHDS180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring systemAn 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.

Contacts#

Phone, Email table
PhoneEmail
800-241-7517hdlberg@etcmail.com

Regulatory Flags#

DUNS number
023287700
Device count
1
Premarket exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B989HMI1180Heidelberg pH Capsule SystemHeidelberg Interface ModuleHMI1182020-11-13
B989HMT00180Heidelberg pH Capsule SystemHeidelberg Medallion TransceiverHMT00182020-11-13
B989HTC1020Heidelberg pH Capsule SystemHeidelberg pH Telemetric CapsulesHTC1022020-11-13
B989EC1150Heidelberg pH Capsule SystemHeidelberg System Equipment CartEC1152020-11-13
B989HCNS180Heidelberg pH Capsule SystemHeidelberg pH Capsule System Software HCNS182020-11-13
B989PCCK3300Heidelberg pH Capsule SystemHeidelberg pH Capsule Calibration KitPCCK3302020-11-13

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Primary DI, Brand, Company table
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