Identity
- Trade Name
- Heidelberg pH Capsule System FDA UDI
- Generic Name
- Gastrointestinal telemetric monitoring system transceiver FDA UDI
- Device Name
- The Medallion Transceiver is a battery powered device of the Heidelberg pH Capsule system, designed to be worn by the patient. The transceiver continuously monitors and transmits information from the Heidelberg pH capsule. The transceiver’s internal firmware also monitors the pH capsule’s strength in real time, calibration accuracy and pH levels. The pH capsule’s information received by the transceiver is sent by telemetry to the Heidelberg interface module. The Interface module forwards the Medallion Transceiver’s information to the computer for display. FDA UDI
- Model / Reference
- Heidelberg Medallion Transceiver FDA UDI
- Description
- The Medallion Transceiver is a battery powered device of the Heidelberg pH Capsule system, designed to be worn by the patient. The transceiver continuously monitors and transmits information from the Heidelberg pH capsule. The transceiver’s internal firmware also monitors the pH capsule’s strength in real time, calibration accuracy and pH levels. The pH capsule’s information received by the transceiver is sent by telemetry to the Heidelberg interface module. The Interface module forwards the Medallion Transceiver’s information to the computer for display. FDA UDI
Identifiers
- Catalog Number
- HMT0018 FDA UDI
- Primary DI / UDI-DI
- B989HMT00180 FDA UDI
- FDA Product Code
- FFT FDA UDI
- GMDN Term
- Gastrointestinal telemetric monitoring system transceiver 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
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Implantable
No
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Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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Convenience Kit
Yes
FDA UDI
Combination Product
No
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HCT/P
No
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Premarket Exempt
Yes
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Lot / Batch Number
No
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Serial Number
Yes
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
Category: Gastrointestinal telemetric monitoring system transceiver
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 4462c0a9-9108-4b78-a4b0-800b7e65d33c 35 fields · synced May 30, 2026