Alcavis 50

Basic Information

• Brand Name: Alcavis 50
• Primary DI: 00898021000068
• Version / Model: 200 mL Spray
• Catalog Number: 15502
• Company Name: Angelini Pharma Inc.
• Labeler DUNS: 078843940
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-29
• Public Version: 7
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 309c971e-4fcc-4bec-925f-14323bf651c0

Device Description

Electrolytic chloroxidizer high level disinfectant.

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
FKO	Catheter, Peritoneal Dialysis, Single Use	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47631	Medical device disinfection agent	A non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20898021000062	GS1	Case	4	In Commercial Distribution
Primary	00898021000068	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 95 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep the bottle in the upright position.
• Type: Special Storage Condition, Specify
• Special Conditions: Alcavis 50 should be stored in closed containers and shielded from direct sun light.