Home GUDID 04260167483559 Versaflex
Primary DI 04260167483559
Brand Versaflex
Company Given Imaging, Inc.
Model 957914
Catalog number 957914
Device description Disposable pH Catheter, Dual Sensor, 18cm, ENT, Large Diameter, VNID18/LD+ENT
Published 2018-09-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
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 04260167483559 Package GS1 10 In Commercial Distribution 04260167483825 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260167483559 04260167483559 4260167483559 04260167483825 04260167483825 4260167483825
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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry;Fragile Special Storage Condition, Specify 0 0 Keep dry;Fragile; Storage Environment Temperature 5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 090073722 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 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 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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