Meditherm

Basic Information

• Brand Name: Meditherm
• Primary DI: B7837045001
• Version / Model: IRIS 450
• Catalog Number: 1704500
• Company Name: Meditherm Incorporated
• Labeler DUNS: 118282031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-18
• Public Version: 1
• Public Version Date: 2022-05-26
• Public Version Status: New
• Public Device Record Key: d48ffc1b-f5ed-4129-a0bc-0ccf8c739c06

Device Description

Thermal Imaging Camera

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHQ	System, Telethermographic (Adjunctive Use)	Obstetrics/Gynecology	884.2980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40803	Infrared thermography system	A system using infrared photography or other infrared detection techniques to produce images or graphical representations of the distribution of body surface temperature for the purpose of diagnosing and assessing various conditions and disease states. Also referred to as a thermography scanner. This system typically consists of a camera display unit that includes a scanning-condensing optical system, infrared detector, an operator's console, photographic cameras, black-body phantom, electronic or computerized controls, software and an image display and analysis units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B7837045001	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K003332	000