Heidelberg pH Capsule System HTC102

GUDID B989HTC1020

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.

Heidelberg Medical Inc

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• Primary Device ID: B989HTC1020
• NIH Device Record Key: 054b6129-b7a3-4610-b51e-a8d61211f506
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heidelberg pH Capsule System
• Version Model Number: Heidelberg pH Telemetric Capsules
• Catalog Number: HTC102
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B989HTC1020 [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