FLEBOSET

Basic Information

• Brand Name: FLEBOSET
• Primary DI: 08426314792578
• Version / Model: DOUBLE
• Company Name: LABORATORIOS GRIFOLS SA
• Labeler DUNS: 463720681
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-05
• Public Version: 6
• Public Version Date: 2024-01-08
• Public Version Status: Update
• Public Device Record Key: d6fb350b-b710-4102-b16e-931b20b60c3f
• Distribution End Date: 2024-01-05

Device Description

FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to cannel the solution from the source vials to the infusion set, and b) Pharmacy compounding when used in conjuntion with the Grifill pharmacy compounding device and associated transfers sets. Equipped with a spike on each line and a 0.2um hydrophobic air-filter, it minimizes teh formation of aerosols when preparing/dispensing the source substances.

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
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	28426314792572	GS1	Box	35	Not in Commercial Distribution	2024-01-05
Primary	08426314792578	GS1