Meditherm 706400

GUDID B783706400170601171

Meditherm IRIS digital thermal camera

Meditherm Incorporated

Infrared thermography system

• Primary Device ID: B783706400170601171
• NIH Device Record Key: 4c134544-d634-4a0a-94eb-908d59052d16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meditherm
• Version Model Number: IRIS 640
• Catalog Number: 706400
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B783706400170601171 [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: 2024-01-25
• Device Publish Date: 2024-01-17

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