Flex-Neck®

Basic Information

• Brand Name: Flex-Neck®
• Primary DI: 00884450305997
• Version / Model: 00884450305997
• Catalog Number: CE-1400/B
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-25
• Public Version: 1
• Public Version Date: 2023-04-03
• Public Version Status: New
• Public Device Record Key: 5da9725c-105f-4698-bcaa-4f1d4d37d833

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FJS	Catheter, peritoneal, long-term indwelling	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35944	Peritoneal dialysis catheter adaptor, single-use	A connecting device, often in two pieces, intended to be used to join a peritoneal dialysis catheter to the dialysate line during treatment. It is typically made of plastic or metal and may be used when the devices to be connected are from different manufacturers and not compatible, enabling them to mate, and/or within a mechanical connection system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884450305994	GS1		1	In Commercial Distribution
Primary	00884450305997	GS1
Package	20884450305991	GS1		60	In Commercial Distribution