freeflex+

Basic Information

• Brand Name: freeflex+
• Primary DI: 04250273729931
• Version / Model: Transfer Adapter
• Catalog Number: 2870103
• Company Name: Fresenius Kabi AG
• Labeler DUNS: 315654579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-01
• Public Version: 1
• Public Version Date: 2023-01-09
• Public Version Status: New
• Public Device Record Key: eae7c0e7-c5d6-4441-9ce2-ef67ec02b63e

Device Description

Reconstitute and/or admix drugs prior to administration to the patient. The device may be used for pediatric and adult populations.

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: MR Safe
• 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
LHI	Set, I.V. Fluid Transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43324	Fluid transfer set, general-purpose	A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04250273716818	GS1	Box	100	In Commercial Distribution
Primary	04250273729931	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K212445	000