Chemical Indicator Label SBD-138

GUDID 00732224756448

3/8" Blue Steam Dot

CROSSTEX INTERNATIONAL, INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 00732224756448
• NIH Device Record Key: b2aa7ea7-6ddc-424e-a9f3-2dca2fd21c12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chemical Indicator Label
• Version Model Number: SBD-138
• Catalog Number: SBD-138
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 10000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224756448 [Unit of Use]
GS1	10732224756445 [Primary]

FDA Product Code

• JOJ: Indicator, physical/chemical 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: 2024-04-12
• Device Publish Date: 2024-04-04

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