AccessGUDID - DEVICE: Restech (00899994002103)

GUDID

Device Identifier (DI) Information

Brand Name: Restech
Version or Model: Dx-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Respiratory Technology Corporation

Primary DI Number: 00899994002103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 603198735 *Terms of Use

Device Description: The Restech Dx–pH Measurement System is intended for gastroesophageal pH measurement and monitoring of gastric reflux. The pH data Recorder and data viewing program are intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36965	Gastric pH ambulatory recorder	An electrically-powered device intended for 24-hour recording of the gastric acidity of the stomach through the use of a dedicated sensor. The patient is connected to and wears the device during the recording period and/or while he or she performs normal daily activities. The results will be later analysed using an appropriate device that can read and display the recording.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFT	Electrode, Ph, Stomach

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad2b99c1-9664-41dc-865a-cbb48ee79106
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022