SteriCUBE Filter Kit + SteriCUBE-PACK-025-FCSKIT

GUDID 00851489007222

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

Stericube, LLC

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• Primary Device ID: 00851489007222
• NIH Device Record Key: a9062dae-1f2c-448c-88df-530b7c1d07b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriCUBE Filter Kit +
• Version Model Number: SteriCUBE-PACK-025-FCSKIT
• Catalog Number: SteriCUBE-PACK-025-FCSKIT
• Company DUNS: 079665067
• Company Name: Stericube, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com
• Phone: 908-300-7093
• Email: mem.pmbs@gmail.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851489007222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152014

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-30
• Device Publish Date: 2024-01-22

Devices Manufactured by Stericube, LLC

• 00851489007222 - SteriCUBE Filter Kit +: 2024-01-30Filter Kit - 25 Cycles, including Filters, Indicator Locks, Ceramic Drain Filter, and Filter Separator
• 00851489007222 - SteriCUBE Filter Kit +: 2024-01-30 Filter Kit - 25 Cycles, including Filters, Indicator Locks, Ceramic Drain Filter, and Filter Separator
• 00851489007239 - SteriCUBE 225 Cabinet, STERIS 600: 2024-01-30 SteriCUBE 225 Cabinet, STERIS 600
• 00851489007246 - SteriCUBE 225 Transfer Cart, STERIS 600: 2024-01-30 SteriCUBE 225 Transfer Cart, STERIS 600