AccessGUDID - DEVICE: Impedance/pH, 6 imp channels, 1 pH antimony, LES locator (08717775954071)

GUDID

Device Identifier (DI) Information

Brand Name: Impedance/pH, 6 imp channels, 1 pH antimony, LES locator
Version or Model: MMS-Z1-A-LES
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medical Measurement Systems B.V.

Primary DI Number: 08717775954071
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 416277333 *Terms of Use

Device Description: Adult, 6.9 Fr

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":	Yes
For Single-Use:	Yes
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?
11600	Oesophageal motility analysis system	An assembly of devices designed to evaluate peristaltic motility in the oesophagus by measuring pressure on an intraluminal catheter/probe at several points (including LES); it also measures pH, respiration, and swallowing with appropriate sensors. In addition to a monitor display, computer, and software, it usually includes nonperfusion catheters to measure pressures directly and/or perfusion catheters and extracorporeal transducers to measure pressure indirectly. The system is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), and/or noncardiac chest pain; it is also used to assess connective tissue and neuromuscular disease.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FFX	SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5837e879-9349-4c48-a443-42854bef9998
Public Version Date: October 19, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016