Home GUDID 06946332800625 alpHaONE
Primary DI 06946332800625
Brand alpHaONE
Company Chongqing Jinshan Science & Technology (Group) Co., Ltd
Model JSPC-1
Device description pH capsule, 1 pack
Published 2021-07-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
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 06946332800625 Package GS1 2 In Commercial Distribution 06946332800632 Package GS1 5 In Commercial Distribution 06946332800045 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06946332800625 06946332800625 6946332800625 06946332800632 06946332800632 6946332800632 06946332800045 06946332800045 6946332800045
GMDN Terms# Term, Definition table Term Definition Gastrointestinal telemetric monitoring system capsule, ingested A battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless signal transmission of one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 86 KiloPascal 106 KiloPascal Storage Environment Humidity 0 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 5 Degrees Celsius 45 Degrees Celsius
Regulatory Flags# DUNS number 545245755 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 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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