AccessGUDID - DEVICE: alpHaONE (06946332804203)

GUDID

Device Identifier (DI) Information

Brand Name: alpHaONE
Version or Model: JSPR-3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chongqing Jinshan Science & Technology (Group) Co., Ltd

Primary DI Number: 06946332804203
Issuing Agency: GS1
Commercial Distribution End Date: January 13, 2033
Device Count: 1
Labeler D-U-N-S® Number*: 545245755 *Terms of Use

Device Description: Recorder for ph capsule

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1bc3a5aa-1f16-4568-aa5e-e8e6aeb48e0d
Public Version Date: January 31, 2023
Public Version Number: 1
DI Record Publish Date: January 23, 2023