LumenCare Azure

Basic Information

• Brand Name: LumenCare Azure
• Primary DI: 08717213056770
• Version / Model: 110691-02
• Company Name: Nucletron B.V.
• Labeler DUNS: 415269930
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-16
• Public Version: 1
• Public Version Date: 2020-05-25
• Public Version Status: New
• Public Device Record Key: 87b82dc7-f72a-4d1d-acaa-d0dd36026f03

Device Description

LumenCare Azure Set 5F, 140cm

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAQ	System, applicator, radionuclide, remote-controlled	Radiology	892.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38411	Bronchial brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in bronchial radiation therapy treatments. It is designed for temporary placement within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the bronchial area. This GMDN code includes a variety of applicators, e.g., hollow needles, tubes or catheters, and their associated components.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717213056770	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132874	000

Device Sizes

Type	Value	Unit	Text
Length	140.0	Centimeter
Catheter Gauge	5.0	French