FDA.reportPublic FDA data

Heidelberg pH Capsule System

Primary DI
B989HMT00180
Brand
Heidelberg pH Capsule System
Company
Heidelberg Medical Inc
Model
Heidelberg Medallion Transceiver
Catalog number
HMT0018
Device description
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.
Published
2020-11-13
Public version status
Update
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
B989HMT00180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring system transceiverA battery-powered component of a gastrointestinal telemetric monitoring system designed to be worn by a patient 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), and transmit the signals to an appropriate device (e.g., computer, monitor) for further processing and/or display. It may have data recording/storage capabilities.

Sterilization Methods#

Method table
Method

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
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
B989HPHDS180Heidelberg pH Capsule SystemHeidelberg pH Capsule SystemHPHDS182020-11-13
B989PCCK3300Heidelberg pH Capsule SystemHeidelberg pH Capsule Calibration KitPCCK3302020-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816734022467Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFT2023-06-30
06946332804173alpHaONEChongqing Jinshan Science & Technology (Group) Co., LtdFFT2023-01-23
06946332804203alpHaONEChongqing Jinshan Science & Technology (Group) Co., LtdFFT2023-01-23
00899994002097RestechThe Reflux CompanyFFT2022-12-02
00899994002103RestechThe Reflux CompanyFFT2022-12-02
00899994002110RestechThe Reflux CompanyFFT2022-12-02
00899994002127RestechThe Reflux CompanyFFT2022-12-02
00899994002134RestechThe Reflux CompanyFFT2022-12-02
00899994002141RestechThe Reflux CompanyFFT2022-12-02
06946332800045alpHaONEChongqing Jinshan Science & Technology (Group) Co., LtdFFT2021-07-01
06946332800625alpHaONEChongqing Jinshan Science & Technology (Group) Co., LtdFFT2021-07-01
06946332800649alpHaONEChongqing Jinshan Science & Technology (Group) Co., LtdFFT2021-07-01
B989EC1150Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
B989HCNS180Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
B989HPHDS180Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
B989PCCK3300Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
B989HMI1180Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
B989HTC1020Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
00816734022726Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFT2019-10-02
07290101369691BravoGiven Imaging, Inc.FFT2019-08-11
07290101361695BravoGiven Imaging, Inc.FFT2018-09-26
07290101364771BravoGiven Imaging, Inc.FFT2018-09-26
07290101365303BravoGiven Imaging, Inc.FFT2018-09-26
07290101366393BravoGiven Imaging, Inc.FFT2018-09-26
07290101364283NAGiven Imaging, Inc.FFT2018-09-07
04260167483825VersaflexGiven Imaging, Inc.FFT2018-09-06
04260167483559VersaflexGiven Imaging, Inc.FFT2018-09-06
07290101363064BravoGiven Imaging, Inc.FFT2018-09-06
04260167483740VersaflexGiven Imaging, Inc.FFT2018-08-29
04260167483757VersaflexGiven Imaging, Inc.FFT2018-08-29