ConFirm 24 Steam Biological Indicators CSBI25

GUDID 50732224000447

Self-Contained Biological Indicator, 24 hour incubation

SPS Medical Supply Corp.

Biological sterilization indicator

• Primary Device ID: 50732224000447
• NIH Device Record Key: cacd0d99-25ec-437f-a62b-c682fe526910
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ConFirm 24 Steam Biological Indicators
• Version Model Number: CSBI25
• Catalog Number: CSBI25
• Company DUNS: 194877072
• Company Name: SPS Medical Supply Corp.
• Device Count: 25
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false

Customer Support Contacts

• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from sterilants or other chemicals

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224000442 [Unit of Use]
GS1	10732224000449 [Primary]
GS1	50732224000447 [Package]; Contains: 10732224000449; Package: case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111515

FDA Product Code

• FRC: Indicator, biological sterilization process

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: 2023-08-18
• Device Publish Date: 2023-08-10

Devices Manufactured by SPS Medical Supply Corp.

• 10732224720132 - SporView SELF-CONTAINED EO GAS BI: 2024-03-19 In-office biological indicators for use in monitoring the efficacy of EO Gas processes.
• 10732224720149 - SporView SELF-CONTAINED EO GAS BI: 2024-03-19 In-office biological indicators for use in monitoring the efficacy of EO Gas processes.
• 50732224720017 - PASSPORT MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720024 - PASSPORT MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720031 - PassPort MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720048 - PassPort MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720796 - PASSPORT PLUS MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720802 - PASSPORT PLUS MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.