EsoFLIP

Basic Information

• Brand Name: EsoFLIP
• Primary DI: 10884521809451
• Version / Model: ES-330
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-15
• Public Version: 5
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 677997fc-5114-47e9-a5e8-33f22988ff6e

Device Description

CATHETER ES-330 30MM ESO DILATION

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
PID	esophageal dilator balloon with or without electrode sensors	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45712	Gastrointestinal/biliary dilation balloon catheter	A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521809458	GS1	PACK_OR_INNER_PACK	5	In Commercial Distribution
Primary	10884521809451	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132337	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: .5 – 1.06 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 20 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: .7 – 1.06 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 0 – 25 Degrees Celsius