Home GUDID 07290101363064 Bravo
Primary DI 07290101363064
Brand Bravo
Company Given Imaging, Inc.
Model FGS-0450
Device description pH recorder
Published 2018-09-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FFT Electrode, pH, stomach
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFT Electrode, Ph, Stomach Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290101363064 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290101363064 07290101363064 7290101363064
GMDN Terms# Term, Definition table Term Definition Gastrointestinal telemetric monitoring system An 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 ;
Regulatory Flags# DUNS number 090073722 Device count 1 Premarket exempt true Serial number true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816734022467 Diversatek Healthcare DIVERSATEK HEALTHCARE, INC. FFT 2023-06-30 06946332804173 alpHaONE Chongqing Jinshan Science & Technology (Group) Co., Ltd FFT 2023-01-23 06946332804203 alpHaONE Chongqing Jinshan Science & Technology (Group) Co., Ltd FFT 2023-01-23 00899994002097 Restech The Reflux Company FFT 2022-12-02 00899994002103 Restech The Reflux Company FFT 2022-12-02 00899994002110 Restech The Reflux Company FFT 2022-12-02 00899994002127 Restech The Reflux Company FFT 2022-12-02 00899994002134 Restech The Reflux Company FFT 2022-12-02 00899994002141 Restech The Reflux Company FFT 2022-12-02 06946332800045 alpHaONE Chongqing Jinshan Science & Technology (Group) Co., Ltd FFT 2021-07-01 06946332800625 alpHaONE Chongqing Jinshan Science & Technology (Group) Co., Ltd FFT 2021-07-01 06946332800649 alpHaONE Chongqing Jinshan Science & Technology (Group) Co., Ltd FFT 2021-07-01 B989EC1150 Heidelberg pH Capsule System Heidelberg Medical Inc FFT 2020-11-13 B989HCNS180 Heidelberg pH Capsule System Heidelberg Medical Inc FFT 2020-11-13 B989HPHDS180 Heidelberg pH Capsule System Heidelberg Medical Inc FFT 2020-11-13 B989PCCK3300 Heidelberg pH Capsule System Heidelberg Medical Inc FFT 2020-11-13 B989HMI1180 Heidelberg pH Capsule System Heidelberg Medical Inc FFT 2020-11-13 B989HMT00180 Heidelberg pH Capsule System Heidelberg Medical Inc FFT 2020-11-13 B989HTC1020 Heidelberg pH Capsule System Heidelberg Medical Inc FFT 2020-11-13 00816734022726 Diversatek Healthcare DIVERSATEK HEALTHCARE, INC. FFT 2019-10-02 07290101369691 Bravo Given Imaging, Inc. FFT 2019-08-11 07290101361695 Bravo Given Imaging, Inc. FFT 2018-09-26 07290101364771 Bravo Given Imaging, Inc. FFT 2018-09-26 07290101365303 Bravo Given Imaging, Inc. FFT 2018-09-26 07290101366393 Bravo Given Imaging, Inc. FFT 2018-09-26 07290101364283 NA Given Imaging, Inc. FFT 2018-09-07 04260167483825 Versaflex Given Imaging, Inc. FFT 2018-09-06 04260167483559 Versaflex Given Imaging, Inc. FFT 2018-09-06 04260167483740 Versaflex Given Imaging, Inc. FFT 2018-08-29 04260167483757 Versaflex Given Imaging, Inc. FFT 2018-08-29
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