Medicom® AssureCheck™

GUDID 00686864060895

Medicom AssureCheck 10HR Steam Biological Indicator

AMD Medicom Inc

Biological sterilization indicator

• Primary Device ID: 00686864060895
• NIH Device Record Key: 4de1a4d2-b792-4ef9-9f8c-11ce42d096d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medicom® AssureCheck™
• Version Model Number: ST1010
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 25
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: 1(514)636-6262
• Email: mkansou@medicom.ca

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864060895 [Unit of Use]
GS1	10686864060892 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093794

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: 2024-10-22
• Device Publish Date: 2024-10-14

Devices Manufactured by AMD Medicom Inc

• 20686864061162 - Medicom SafeSeal: 2025-03-28 Medicom SafeSeal Tan Steam Sterilization Indicator Tape - 0.75" x 60 yards
• 00686864061144 - MEDICOM DENTICARE: 2025-03-26 MEDICOM DENTICARE SWIVEL DPA, Sample Pack
• 00686864061151 - MEDICOM SAFEMATRIX: 2025-03-26 Medicom SafeMatrix, single use, sample pack
• 00686864061328 - MEDICOM: 2025-03-26 MEDICOM, Face Masks, sample pack
• 20686864061223 - MEDICOM SAFEWEAR: 2025-02-14 Medicom SafeWear Hipster Jacket - Jet Black - Premium Hip Length Jacket - Jet Black - 2X-Large
• 20686864056816 - Medicom SafeMask: 2025-01-31 Medicom SafeMask Architect - Procedure Earloop Face Masks - Level 3 - Blue
• 20686864058599 - Medicom SafeMask: 2025-01-31 Medicom SafeMask Architect JR - Pediatric Procedure Earloop Face Masks - Level 1 - Blue
• 20686864061278 - RITMED: 2025-01-14 Ritmed Precision - Isolation gown with over-the-head design - AAMI Level 2 - Yellow - Large