FDA.reportPublic FDA data

Heidelberg pH Capsule System

Primary DI
B989EC1150
Brand
Heidelberg pH Capsule System
Company
Heidelberg Medical Inc
Model
Heidelberg System Equipment Cart
Catalog number
EC115
Device description
The cart (trolley) is a Non-Metallic 3 shelf mobile equipment cart, is used for transporting the Heidelberg pH Capsule systems devices.
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
B989EC1150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Utility trolleyA cart designed for transporting/supplying general-purpose goods, devices, medical equipment, or supplies within a hospital/institution department or ward. This trolley (cart) may have one or more open platforms and may have a handle(s) for pushing the trolley.

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
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
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
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