AccessGUDID - DEVICE: alpHaONE (06946332800045)

GUDID

Device Identifier (DI) Information

Brand Name: alpHaONE
Version or Model: JSPC-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chongqing Jinshan Science & Technology (Group) Co., Ltd

Primary DI Number: 06946332800045
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2030
Device Count: 1
Labeler D-U-N-S® Number*: 545245755 *Terms of Use

Device Description: pH capsule, 1 pack

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFT	Electrode, Ph, Stomach

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 45 Degrees Celsius
Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Storage Environment Humidity: less than 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d410f2fd-1270-40da-b676-3c3ee4c4a50c
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: July 01, 2021