FDA.reportPublic FDA data

Heidelberg pH Capsule System

Primary DI
B989HCNS180
Brand
Heidelberg pH Capsule System
Company
Heidelberg Medical Inc
Model
Heidelberg pH Capsule System Software
Catalog number
HCNS18
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.
Published
2020-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B989HCNS180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring system application softwareA 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.

Contacts#

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

Regulatory Flags#

DUNS number
023287700
Device count
1
Premarket exempt
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
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
B989HPHDS180Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
B989PCCK3300Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
B989HMI1180Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
B989HMT00180Heidelberg 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