Firefly IPA Bottle

Basic Information

• Brand Name: Firefly IPA Bottle
• Primary DI: 00865349000353
• Version / Model: 40595
• 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: 5
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: f6e9086d-8378-4744-9b4b-f0b19772fbb4
• Distribution End Date: 2016-12-01

Device Description

99% IPA bottle for use with the Firefly system

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: Yes
• 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
61141	Luer-formatted disinfection cap	A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00865349000353	GS1

Customer Contacts

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