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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 receiver FDA UDI
Device Name
The interface module is a stationary electronic component of the Heidelberg pH capsule telemetric monitoring system designed to continuously monitor incoming date from the Heidelberg transceiver. The interface transmits the incoming pH data and events from the transceiver and assigns a specific channel to the data and routes it to the computer for display on one to eight graphs. FDA UDI
Model / Reference
Heidelberg Interface Module FDA UDI
Description
The interface module is a stationary electronic component of the Heidelberg pH capsule telemetric monitoring system designed to continuously monitor incoming date from the Heidelberg transceiver. The interface transmits the incoming pH data and events from the transceiver and assigns a specific channel to the data and routes it to the computer for display on one to eight graphs. FDA UDI

Identifiers

Catalog Number
HMI118 FDA UDI
Primary DI / UDI-DI
B989HMI1180 FDA UDI
FDA Product Code
FFT FDA UDI
GMDN Term
Gastrointestinal telemetric monitoring system receiver 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Gastrointestinal telemetric monitoring system receiver

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

Similar devices

Also classified as Gastrointestinal telemetric monitoring system receiver.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Heidelberg Medical Inc

Sources (1)

  • FDA UDI 94a592b4-1624-4eb3-aa78-288ac670af29 35 fields · synced Jun 1, 2026