Home GUDID 00899994002134 Restech
Primary DI 00899994002134
Brand Restech
Company The Reflux Company
Model Dx-201 P
Device description Primus pH probe. Intended for oropharyngeal pH measurement.
Published 2022-12-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use 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 00899994002134 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00899994002134 00899994002134 899994002134 0899994002134
GMDN Terms# Term, Definition table Term Definition Gastric pH ambulatory recorder An electrically-powered device intended for 24-hour recording of the gastric acidity of the stomach through the use of a dedicated sensor. The patient is connected to and wears the device during the recording period and/or while he or she performs normal daily activities. The results will be later analysed using an appropriate device that can read and display the recording.
Regulatory Flags# DUNS number 144845049 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true No natural rubber latex 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 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 07290101363064 Bravo 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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