Banicide Plus Sterilizing and Disinfecting Solution

Basic Information

• Brand Name: Banicide Plus Sterilizing and Disinfecting Solution
• Primary DI: 00310866000008
• Version / Model: 15200
• Catalog Number: 15200
• Company Name: PASCAL COMPANY, INC.
• Labeler DUNS: 009260217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-29
• Public Version: 1
• Public Version Date: 2019-03-01
• Public Version Status: New
• Public Device Record Key: 6cc78f29-9523-41ab-87ec-f12eb3c83bd9

Device Description

Reusable 3.4% Glutaraldehyde Sterilizing & Disinfecting Solution; 1 gallon Sterilization, high level disinfection and cleaning/decontamination solution.

Device Characteristics

• Single Use: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MED	Sterilant, Medical Devices	General Hospital	880.6885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40579	Glutaraldehyde device sterilant	A liquid substance that includes glutaraldehyde as its primary agent intended to completely destroy or eliminate (sterilize) all harmful microorganisms on a medical device (e.g., surgical or dental instrument); it may also be intended for use as a high-level disinfectant. The medical device is typically bathed by the substance for a specified period of time in order to achieve high-level disinfection or sterilization. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00310866000008	GS1
Package	20310866000002	GS1	Pallet	144	In Commercial Distribution
Package	10310866000005	GS1	Case	4	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit