Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit

Basic Information

• Brand Name: Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit
• Primary DI: 10853072007210
• Version / Model: 320111
• Catalog Number: 320111
• Company Name: Nuwellis Inc.
• Labeler DUNS: 790580182
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-20
• Public Version: 1
• Public Version Date: 2024-02-28
• Public Version Status: New
• Public Device Record Key: 36974163-3d16-46e5-9c83-3b1dc52befec

Device Description

This Kit includes a dELC Catheter (11cm) and a GALT Insertion Kit. The dELC is a 6 F reverse taper dual lumen venous access device with stainless steel coil reinforcement, designed specifically for use with the Aquadex systems. The catheter is inserted into the peripheral venous circulation by way of a peel away introducer.

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
NQJ	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46979	Double-lumen haemodialysis catheter, nonimplantable	A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30853072007221	GS1	Box	5	In Commercial Distribution
Primary	10853072007210	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K233515	000

Device Sizes

Type	Value	Unit	Text
Catheter Working Length	11	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius