Metricide

GUDID 10615375008574

OPA TEST STRIPS - 100 COUNT 2 BOTTLES/CS

METREX RESEARCH, LLC

Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip Ortho-phthalaldehyde (OPA) device disinfectant test strip

• Primary Device ID: 10615375008574
• NIH Device Record Key: 0e099365-6c3a-4bba-ae00-5417edca4067
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metricide
• Version Model Number: 10-602
• Company DUNS: 145963778
• Company Name: METREX RESEARCH, LLC
• Device Count: 100
• 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: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com
• Phone: 18008411428
• Email: customercare@kavokerrgroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615375007853 [Unit of Use]
GS1	00615375008577 [Primary]
GS1	10615375008574 [Package]; Contains: 00615375008577; Package: Bottle [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070419

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: 2023-11-01
• Device Publish Date: 2023-10-24

On-Brand Devices [Metricide]

• H97110140522: Sterilizing & Disinfecting Solution 14Day Glutaraldehyde Dialdehyde Solution 2.6% Glutaraldehy
• H9711014002: Sterilizing & Disinfecting Solution 14Day Glutaraldehyde Dialdehyde Solution 2.6% Glutaraldehy
• 10615375008574: OPA TEST STRIPS - 100 COUNT 2 BOTTLES/CS