AccessGUDID - DEVICE: Heidelberg pH Capsule System (B989HCNS180)

GUDID

Device Identifier (DI) Information

Brand Name: Heidelberg pH Capsule System
Version or Model: Heidelberg pH Capsule System Software
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HCNS18
Company Name: Heidelberg Medical Inc

Primary DI Number: B989HCNS180
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023287700 *Terms of Use

Device Description: The Heidelberg pH capsule system software package intended to add image processing and/or analysis capabilities to a gastric and gastrointestinal telemetric monitoring system used to help diagnose gastric pH disorders and/or measure gastric and gastrointestinal pH via wirelessly transmitted signals from a pH telemetric capsule swallowed by the patient. It may be installed in a portable hand-held receiver or in a computing device to which measured data that is transmitted by a transceiver.

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):	No
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?
58358	Gastrointestinal telemetric monitoring system application software	A software package intended to add image processing and/or analysis capabilities to a gastrointestinal telemetric monitoring system used to help diagnose gastric pH disorders and/or measure gastrointestinal transit times via wirelessly transmitted signals from a capsule swallowed by the patient. It may be installed in a portable hand-held receiver or in a computing device to which measured data is transmitted by a transceiver.	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: 9605b7a1-f502-4c58-bdc5-a1b20795c6d9
Public Version Date: November 23, 2020
Public Version Number: 1
DI Record Publish Date: November 13, 2020