EndoFLIP

Basic Information

• Brand Name: EndoFLIP
• Primary DI: 05391530810029
• Version / Model: EF-322
• Company Name: CROSPON LIMITED
• Labeler DUNS: 989779517
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-02
• Public Version: 7
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: 5447d2f0-0090-4683-b082-7262081f9ffa

Device Description

EndoFLIP Measurement Catheter for use with EndoFLIP System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	876.1725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete
35053	Manometric gastrointestinal motility analysis system	An assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.	No	Active
45569	Gastrointestinal 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391530810029	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K120997	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 25 Degrees Celsius