Kabi Access Infusion Sets

Basic Information

• Brand Name: Kabi Access Infusion Sets
• Primary DI: 10813153027988
• Version / Model: FK20219KE
• Company Name: Codan US Corporation
• Labeler DUNS: 058027475
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-27
• Public Version: 1
• Public Version Date: 2025-09-04
• Public Version Status: New
• Public Device Record Key: d246d4f1-f582-4eca-9b76-75b565370a57

Device Description

Short Extension Set T-Connector

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00813153027981	GS1	Multivac packaging	1	In Commercial Distribution
Primary	10813153027988	GS1