← Back to catalogue

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 capsule, ingestible FDA UDI
Device Name
The capsule is a physiologic battery-powered device used for gastric monitoring and data collection. The tethered pH capsule is swallowed by the patient. The information gathered by the capsule contains one or more gastric parameters (i.e., pH, events and or gastric bleeding, delayed stomach emptying, or gastric dumping). The capsule is comprised of a sensor for monitoring gastric pH and movement. The telemetric signals produced by the pH capsule are detected by the patient worn transceiver. The capsules data is transmitted from the transceiver to the Heidelberg Interface module. The interface module sends the capsule information to the computer. The computer software interprets the capsule data and displays it on computer generated graph. This is a single-use device. FDA UDI
Model / Reference
Heidelberg pH Telemetric Capsules FDA UDI
Description
The capsule is a physiologic battery-powered device used for gastric monitoring and data collection. The tethered pH capsule is swallowed by the patient. The information gathered by the capsule contains one or more gastric parameters (i.e., pH, events and or gastric bleeding, delayed stomach emptying, or gastric dumping). The capsule is comprised of a sensor for monitoring gastric pH and movement. The telemetric signals produced by the pH capsule are detected by the patient worn transceiver. The capsules data is transmitted from the transceiver to the Heidelberg Interface module. The interface module sends the capsule information to the computer. The computer software interprets the capsule data and displays it on computer generated graph. This is a single-use device. FDA UDI

Identifiers

Catalog Number
HTC102 FDA UDI
Primary DI / UDI-DI
B989HTC1020 FDA UDI
FDA Product Code
FFT FDA UDI
GMDN Term
Gastrointestinal telemetric monitoring system capsule, ingestible 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastrointestinal telemetric monitoring system capsule, ingestible

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 capsule, ingestible.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Heidelberg Medical Inc

Sources (1)

  • FDA UDI 054b6129-b7a3-4610-b51e-a8d61211f506 36 fields · synced May 30, 2026