SteriCUBE Filter Kit +

Basic Information

• Brand Name: SteriCUBE Filter Kit +
• Primary DI: 00851489007222
• Version / Model: SteriCUBE-PACK-025-FCSKIT
• Catalog Number: SteriCUBE-PACK-025-FCSKIT
• Company Name: Stericube, LLC
• Labeler DUNS: 079665067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-22
• Public Version: 1
• Public Version Date: 2024-01-30
• Public Version Status: New
• Public Device Record Key: a9062dae-1f2c-448c-88df-530b7c1d07b4

Device Description

Filter Kit - 25 Cycles, including Filters, Indicator Locks, Ceramic Drain Filter, and Filter Separator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60909	Sterilization container filter, single-use	A device designed to function as a microbial barrier in containers used for steam or solvent sterilization. It allows penetration of the sterilization agent as it prevents the passage of microorganisms. It is typically made of a thin, porous, non-woven fabric material or paper. This is a single-use device.	No	Active
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851489007222	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152014	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 75 Degrees Fahrenheit