FOGARTY

Basic Information

• Brand Name: FOGARTY
• Primary DI: 00690103043587
• Version / Model: 2202310F
• Catalog Number: 2202310F
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-03
• Public Version: 3
• Public Version Date: 2019-02-21
• Public Version Status: Update
• Public Device Record Key: 41d1dee2-d7f7-469d-b014-6fb66997e737

Device Description

FOGARTY IRRIGATION CATHETER 10F, 23CM

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBX	CATHETER, IRRIGATION	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62649	Biliary/vascular irrigation catheter	A sterile, flexible, single-lumen tube intended to access the biliary system during open surgery to introduce fluids (e.g., saline) to irrigate the lumen following a procedure to remove debris (e.g., biliary stone removal); it might additionally be intended to access the peripheral vascular system to introduce fluids (e.g., heparinized solution) to remove debris (e.g., thrombectomy). The device is not intended for percutaneous or endoscopic access, and is not intended for drainage/suction or wound irrigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103043587	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			USABLE LENGTH: 23CM, FRENCH SIZE: 10F (3.3MM)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE IN A COOL, DRY PLACE.