alpHaONE

Basic Information

• Brand Name: alpHaONE
• Primary DI: 06946332804173
• Version / Model: JSPC-1
• Company Name: Chongqing Jinshan Science & Technology (Group) Co., Ltd
• Labeler DUNS: 545245755
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-23
• Public Version: 1
• Public Version Date: 2023-01-31
• Public Version Status: New
• Public Device Record Key: 2199dbfa-79ae-4db3-ac52-90ee26df6497
• Distribution End Date: 2033-06-01

Device Description

pH capsule

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFT	Electrode, Ph, Stomach	Gastroenterology, Urology	876.1400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62385	Gastrointestinal telemetric monitoring system capsule, ingestible	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16946332804170	GS1	box	5	In Commercial Distribution	2033-06-01
Primary	06946332804173	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 45 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 86 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity