DEVICE: EndoFLIP (05391530810005)

Download: XML | JSON

Device Identifier (DI) Information

EndoFLIP
EF-325N

CROSPON LIMITED
05391530810005
GS1
1
EndoFLIP Measurement Catheter for use with EndoFLIP System
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
Gastrointestinal motility analysis system, invasive An assembly of devices designed to evaluate peristaltic motility anywhere in the gastrointestinal (GI) tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure on an intraluminal catheter/probe placed in the GI tract. It is intended to record, view, and analyse pH, impedance, pressure, and various other input data (e.g., respirations) to assist in the diagnosis and evaluation of GI motility disorders (e.g., dysphagia). The assembly typically includes a monitor display, computer, software, and dedicated measuring probes.
Barostat A computerized pneumatic device designed to measure tension-sensory threshold and motility in the gastrointestinal tract during neurogastroenterology assessment. It maintains a preselected pressure in an intragastric bag (balloon) of a dedicated catheter that is inserted into the gastrointestinal tract (e.g., oesophagus, stomach, intestines, rectum) and registers the pressure changes of the air pumped into the balloon at a predetermined speed (internal pressure data), and simultaneously measures the volume of air that has been used. The collected data can be used in the diagnosis of gastrointestinal disorders such as dysphagia, nausea, vomiting, anorexia, bulimia, or constipation.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FFX System, Gastrointestinal Motility (Electrical)
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 25 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
August 02, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05391530810067 5 05391530810005 In Commercial Distribution Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8552767766
info@crospon.com
CLOSE