Restech

GUDID 00899994002127

Dx-500 Recorder - Part of the Dx-1000 pH Measurement system. The pH data Recorder is intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders.

Respiratory Technology Corporation

Gastric pH ambulatory recorder

• Primary Device ID: 00899994002127
• NIH Device Record Key: 6a943f59-b36c-419e-9a45-5fd161d0e119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restech
• Version Model Number: Dx-500
• Company DUNS: 603198735
• Company Name: Respiratory Technology Corporation
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com
• Phone: 858-673-3700
• Email: customerservice@restech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00899994002127 [Primary]

FDA Product Code

• FFT: Electrode, Ph, Stomach

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-12
• Device Publish Date: 2022-12-02

On-Brand Devices [Restech]

• 00899994002141: Long pH probe for esophageal pH measurement.
• 00899994002134: Primus pH probe. Intended for oropharyngeal pH measurement.
• 00899994002127: Dx-500 Recorder - Part of the Dx-1000 pH Measurement system. The pH data Recorder is intended fo
• 00899994002110: Dx-300 Transmitter - Part of the Dx-1000 pH Measurement System. The transmitter is intended for
• 00899994002103: The Restech Dx–pH Measurement System is intended for gastroesophageal pH measurement and monit
• 00899994002097: pH probe. Intended for oropharyngeal pH measurement.