SteriTec Self-Contained BI Steam Box

GUDID 00732224757476

Self-Contained BI Steam Box

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

• Primary Device ID: 00732224757476
• NIH Device Record Key: bb29308d-9b8c-46fc-b8c4-27f96e583e62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriTec Self-Contained BI Steam Box
• Version Model Number: BI-038
• Company DUNS: 194877072
• Company Name: SPS Medical Supply Corp.
• Device Count: 100
• 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: true

Customer Support Contacts

• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224757476 [Unit of Use]
GS1	10732224757473 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-26
• Device Publish Date: 2020-11-18

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.