PASSPORT PLUS MAIL-IN SYSTEM PP-012

GUDID 50732224720796

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 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: 50732224720796
• NIH Device Record Key: 287ed84e-27d7-4410-ab4c-ed4897ec4ba2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASSPORT PLUS MAIL-IN SYSTEM
• Version Model Number: PP-012
• Catalog Number: PP-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	00732224720791 [Unit of Use]
GS1	10732224720798 [Primary]
GS1	50732224720796 [Package]; Contains: 10732224720798; 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 PLUS MAIL-IN SYSTEM]

• 50732224720802: Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and E
• 50732224720796: Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and E