FDA.reportPublic FDA data

Restech

Primary DI
00899994002103
Brand
Restech
Company
The Reflux Company
Model
Dx-1000
Device description
The Restech Dx–pH Measurement System is intended for gastroesophageal pH measurement and monitoring of gastric reflux. The pH data Recorder and data viewing program are intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders.
Published
2022-12-02
Public version status
Update
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
00899994002103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899994002103008999940021038999940021030899994002103

GMDN Terms#

Term, Definition table
TermDefinition
Gastric pH ambulatory recorderAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858-673-3700Customerservice@restech.com
858-397-2200contact@refluxcompany.com

Regulatory Flags#

DUNS number
144845049
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00899994002097RestechDx-201 pH probe CAS2022-12-02
00899994002110RestechDx-3002022-12-02
00899994002127RestechDx-5002022-12-02
00899994002134RestechDx-201 P2022-12-02
00899994002141RestechDx-201 L 2022-12-02
00856219002102Mederi MDRF1 GeneratorMDRF1177-51502016-09-27
00856219002294Stretta8800175-55802016-09-27
00856219002003Secca8000175-51072016-09-27

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
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
B989EC1150Heidelberg pH Capsule SystemHeidelberg Medical IncFFT2020-11-13
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