Dual Species BI Strip DS-100-RED

GUDID 00732224720197

Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical Vapor sterilization processes

CROSSTEX INTERNATIONAL, INC.

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: 00732224720197
• NIH Device Record Key: 2511123a-24b2-4f87-9081-92c2d06279a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Species BI Strip
• Version Model Number: DS-100-RED
• Catalog Number: DS-100-RED
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• 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: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224720197 [Unit of Use]
GS1	10732224720194 [Primary]

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: 2024-04-04
• Device Publish Date: 2024-03-27

On-Brand Devices [Dual Species BI Strip]

• 00732224720159: Dual Spore Strip, Geobacillus stearothermophilus and Bacillus atrophaeus
• 00732224720203: Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical
• 00732224720197: Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical
• 00732224720180: Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical
• 00732224720173: Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical
• 00732224720166: Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical