FOGARTY

Basic Information

• Brand Name: FOGARTY
• Primary DI: 00690103043785
• Version / Model: 830705F
• Catalog Number: 830705F
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 16b3f82f-a487-4875-b050-b7cf18279ece

Device Description

FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
DXF	CATHETER, SEPTOSTOMY	Cardiovascular	870.5175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10747	Cardiac septostomy catheter, balloon	A flexible tube with an inflatable balloon designed to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. This allows interatrial blood mixing in infants with transposition of the great vessels. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103043785	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			BODY LENGTH: 50CM, FRENCH SIZE: 5F (1.67MM)

Storage Conditions

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