NA

Basic Information

• Brand Name: NA
• Primary DI: 00690103043693
• Version / Model: 420804F
• Catalog Number: 420804F
• 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: 4
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: be5da07d-1e17-4fbd-8ae8-4bec3576abc6

Device Description

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER 4F 80CM

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: 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
FGE	CATHETER, BILIARY, DIAGNOSTIC	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16429	ERCP catheter, non-balloon, non-electrical, single-use	A non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103043693	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905707	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			CATHETER SIZE: 4F (1.33MM), CATHETER LENGTH: 80CM

Storage Conditions

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