Meditherm 706400

GUDID B783706400170601171

Meditherm IRIS digital thermal camera

Meditherm Incorporated

Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system Infrared thermography system 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