FDA.reportPublic FDA data

alpHaONE

Primary DI
06946332804173
Brand
alpHaONE
Company
Chongqing Jinshan Science & Technology (Group) Co., Ltd
Model
JSPC-1
Device description
pH capsule
Published
2023-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
16946332804170PackageGS15In Commercial Distribution
06946332804173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694633280417016946332804170
06946332804173069463328041736946332804173

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring system capsule, ingestibleA 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
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+8602386098151Service@jinshangroup.com

Regulatory Flags#

DUNS number
545245755
Device count
1
Premarket exempt
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946332803725BEAMER AVEO IRRIGATION PUMP FOOT PEDAL REPLACEMENT PARTPUMP-12022-02-22
06946332804203alpHaONEJSPR-32023-01-23
06946332800649alpHaONEJSPR-32021-07-01
06946332800045alpHaONEJSPC-12021-07-01
06946332803701BEAMER AVEO IRRIGATION PUMP BOTTLE HOLDER (US/EU) REPLACEMENT PARTPUMP-32022-02-22
06946332803718BEAMER AVEO IRRIGATION PUMP BOTTLE HOLDER (US/EU) REPLACEMENT PARTPUMP-32022-02-22
06946332803732BEAMER AVEO IRRIGATION PUMP FOOT PEDAL REPLACEMENT PARTPUMP-12022-02-22
06946332803749BEAMER AVEO IRRIGATION PUMP HEAD REPLACEMENT PARTPUMP-22022-02-22
06946332803145Beamer AVEO™ Irrigation PumpAVEOPUMP2021-12-31
06946332800625alpHaONEJSPC-12021-07-01
06946332802131GynoVisionJSX-T-62020-09-01
06946332802193GynoVisionJSX-T-72020-09-01
06946332802254GynoVisionJSX-T-82020-09-01
06946332802117GynoVisionJSX-12020-09-01
06946332802148GynoVisionJSX-T-62020-09-01
06946332802209GynoVisionJSX-T-72020-09-01
06946332802261GynoVisionJSX-T-82020-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816734022467Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFT2023-06-30
06946332804203alpHaONEChongqing Jinshan Science & Technology (Group) Co., LtdFFT2023-01-23
00899994002097RestechThe Reflux CompanyFFT2022-12-02
00899994002103RestechThe 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