Meditherm 1704500

GUDID B783704500170501136

Meditherm Incorporated

Infrared thermography system

• Primary Device ID: B783704500170501136
• NIH Device Record Key: e26e89c6-f04b-4157-a141-df3f42971f39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meditherm
• Version Model Number: IRIS 450
• Catalog Number: 1704500
• Company DUNS: 118282031
• Company Name: Meditherm Incorporated
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com
• Phone: 7048472022
• Email: centerforwellness@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B783704500170501136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003332

FDA Product Code

• LHQ: System, Telethermographic (Adjunctive Use)

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: 2022-08-10
• Device Publish Date: 2022-08-02

On-Brand Devices [Meditherm]

• B7837064001: Thermal Imaging Camera
• B7837045001: Thermal Imaging Camera
• B7837045001705011327: IRIS 450
• B7837045001705011226: IRIS 450
• B783704500170501136: IRIS 450
• B7837045001705011237: IRIS 450
• B783704500170601177: IRIS 640
• B783706400170601174: IRIS 640
• B783704500170601129: IRIS 640
• B783706400170601172: IRIS 640
• B783704500170501138: IRIS 450
• B783706400170601130: Digital Thermal Camera
• B783706400170601171: Meditherm IRIS digital thermal camera
• B783706400170601160: Meditherm Digital Thermal Camera
• B783706400170601127: Meditherm Ditigal Thermal Camera
• B783706400170601125: Meditherm Thermal Imaging Camera
• B783706400170601135: Meditherm IRIS Digitel thermal camera
• B783706400170601138: Digital thermal camera
• B783706400170601137: Meditherm IRIS digitsal thermal camera
• B783706400170601136: Digital thermal camera
• B783706400170601133: Digital thermal camera
• B783706400170601143: Digital thermal camera
• B783706400170601140: Digital Thermal Camera
• B783706400170601144: Digital Thermal Imaging camera
• B783706400170601132: Digital Thermal Camera
• B783706400170601147: Meditherm IRIS digital thermal camera
• B783706400170601146: Meditherm IRIS digital thermal camera
• B783706400170601145: Meditherm IRIS Digital thermal camera
• B783706400170601142: Meditherm IRIS digital thermal camera
• B783706400170601141: Meditherm IRIS digital thermal camera
• B783706400170601151: Meditherm Iris Digital Thermal Camera