Nfuze

Basic Information

• Brand Name: Nfuze
• Primary DI: 06972620112880
• Version / Model: HNS003
• Company Name: BQ PLUS MEDICAL CO., LTD.
• Labeler DUNS: 544463583
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-17
• Public Version: 3
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: fa6b48fe-4229-4289-9b45-5636dd2c9d74
• Distribution End Date: 2022-08-12

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: 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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36244	Electronic gravity infusion controller administration set	A collection of devices designed for the intravenous (IV) administration of fluid from a container, through an automated infusion controller, to a catheter/needle hub or extension tube set at the patient site. The collection typically consists of plastic tubing, a check valve, a roller clamp, a Y-piece connector for secondary tubing attachment, and Luer connectors at both ends. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06972620112880	GS1

Premarket Submissions

Submission Number	Supplement Number
K210381	000