PASSPORT MAIL-IN SYSTEM PS-012

GUDID 50732224720017

Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.

SPS Medical Supply Corp.

Biological sterilization indicator

• Primary Device ID: 50732224720017
• NIH Device Record Key: ede651fa-1eac-402c-88cc-686df75a6ad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASSPORT MAIL-IN SYSTEM
• Version Model Number: PS-012
• Catalog Number: PS-012
• Company DUNS: 194877072
• Company Name: SPS Medical Supply Corp.
• Device Count: 12
• DM Exempt: false
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• 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 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224720012 [Unit of Use]
GS1	10732224720019 [Primary]
GS1	50732224720017 [Package]; Contains: 10732224720019; Package: box [10 Units]; In Commercial Distribution

FDA Product Code

• MRB: Indicator, biological, liquid chemical 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: 3
• Public Version Date: 2023-10-09
• Device Publish Date: 2016-11-15

On-Brand Devices [PASSPORT MAIL-IN SYSTEM]

• 50732224720048: Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and E
• 50732224720031: Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and E
• 50732224720024: Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and E
• 50732224720017: Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and E