Heidelberg pH Capsule System

FDA UDI

Class I (US FDA UDI)

by Heidelberg Medical Inc

Identity

Trade Name: Heidelberg pH Capsule System FDA UDI
Generic Name: Gastrointestinal telemetric monitoring system application software FDA UDI
Device Name: 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. FDA UDI
Model / Reference: Heidelberg pH Capsule System Software FDA UDI
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. FDA UDI

Identifiers

Catalog Number: HCNS18 FDA UDI
Primary DI / UDI-DI: B989HCNS180 FDA UDI
FDA Product Code: FFT FDA UDI
GMDN Term: Gastrointestinal telemetric monitoring system application software FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Gastrointestinal telemetric monitoring system application software

Heidelberg pH Capsule System by Heidelberg Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Heidelberg Medical Inc

Sources (1)

FDA UDI 9605b7a1-f502-4c58-bdc5-a1b20795c6d9 35 fields · synced May 30, 2026