ConFirm Value Test Biological Indicator Monitoring Service CVT120

GUDID 50732224000423

Mail-in service for 3rd Party testing and documentation of processed biological indicators. Compatible with steam, EO, chemical vapor and dry heat sterilizers

SPS Medical Supply Corp.

Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator

• Primary Device ID: 50732224000423
• NIH Device Record Key: bc9bde1d-6951-4a0c-9ac8-d4d73995f38d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ConFirm Value Test Biological Indicator Monitoring Service
• Version Model Number: CVT120
• Catalog Number: CVT120
• Company DUNS: 194877072
• Company Name: SPS Medical Supply Corp.
• Device Count: 12
• 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
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place away from sterilizing units and other heat sources or chemical products.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224000428 [Unit of Use]
GS1	10732224000425 [Primary]
GS1	50732224000423 [Package]; Contains: 10732224000425; Package: case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905425

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

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• 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.