Heidelberg pH Capsule System HMT0018

GUDID B989HMT00180

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.

Heidelberg Medical Inc

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• Primary Device ID: B989HMT00180
• NIH Device Record Key: 4462c0a9-9108-4b78-a4b0-800b7e65d33c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heidelberg pH Capsule System
• Version Model Number: Heidelberg Medallion Transceiver
• Catalog Number: HMT0018
• Company DUNS: 023287700
• Company Name: Heidelberg Medical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com
• Phone: 800-241-7517
• Email: hdlberg@etcmail.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B989HMT00180 [Primary]

FDA Product Code

• FFT: Electrode, Ph, Stomach

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-28
• Device Publish Date: 2020-11-13

On-Brand Devices [Heidelberg pH Capsule System]

• B989HTC1020: The capsule is a physiologic battery-powered device used for gastric monitoring and data collect
• B989HMT00180: The Medallion Transceiver is a battery powered device of the Heidelberg pH Capsule system, desig
• B989HMI1180: The interface module is a stationary electronic component of the Heidelberg pH capsule telemetri