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 FDA UDI
Device Name: The Heidelberg pH Capsule system is an assembly of devices designed to continuously monitor, measures and transmit information from the gastric and gastrointestinal systems. The transmitted gastric and gastrointestinal parameters from the pH Capsule are (i.e., pH or events), (e.g., gastric bleeding). The information from the pH capsule is received by the transceiver and then sent through the interface and to the computer. The computer software analyzes the information and displays it on a generated graph. The system assembly includes various solutions, test tubes, fluid containers and pH capsule calibration test fixture. The Heidelberg pH Capsule System is intended to help diagnose varies gastric and gastrointestinal pH related disorders. FDA UDI
Model / Reference: Heidelberg pH Capsule System FDA UDI
Description: The Heidelberg pH Capsule system is an assembly of devices designed to continuously monitor, measures and transmit information from the gastric and gastrointestinal systems. The transmitted gastric and gastrointestinal parameters from the pH Capsule are (i.e., pH or events), (e.g., gastric bleeding). The information from the pH capsule is received by the transceiver and then sent through the interface and to the computer. The computer software analyzes the information and displays it on a generated graph. The system assembly includes various solutions, test tubes, fluid containers and pH capsule calibration test fixture. The Heidelberg pH Capsule System is intended to help diagnose varies gastric and gastrointestinal pH related disorders. FDA UDI

Identifiers

Catalog Number: HPHDS18 FDA UDI
Primary DI / UDI-DI: B989HPHDS180 FDA UDI
FDA Product Code: FFT FDA UDI
GMDN Term: Gastrointestinal telemetric monitoring system 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Gastrointestinal telemetric monitoring system

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

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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 a97b2fed-6f50-47e9-827a-101eb9392e3a 35 fields · synced May 29, 2026