Firefly UV Disinfection Device

Basic Information

• Brand Name: Firefly UV Disinfection Device
• Primary DI: 00865349000308
• Version / Model: 40406
• Company Name: PURACATH MEDICAL, INC
• Labeler DUNS: 963236661
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-21
• Public Version: 3
• Public Version Date: 2020-07-10
• Public Version Status: Update
• Public Device Record Key: 8a1ccc9d-8018-4210-9c26-a0df19c98906
• Distribution End Date: 2016-12-01

Device Description

Battery powered Ultraviolet light disinfection device.

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17434	Peritoneal dialysis system irradiation unit	A mains electricity (AC-powered) device designed to emit ultraviolet radiation in order to keep the field and devices sterile while the appropriate connections between the components of a peritoneal dialysis transfer tubing set are implemented.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00865349000308	GS1

Customer Contacts

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