Bluedrop Medical

Basic Information

• Brand Name: Bluedrop Medical
• Primary DI: 05391536710002
• Version / Model: 05391536710002
• Company Name: BLUEDROP MEDICAL LIMITED
• Labeler DUNS: 985593930
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-18
• Public Version: 1
• Public Version Date: 2023-09-26
• Public Version Status: New
• Public Device Record Key: c57d2111-3545-4e7f-8f7e-93cbaac3c1e8

Device Description

Foot examination tool for inflamatory changes

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OIZ	Foot Examination Tool For Inflammatory Changes	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36731	Thermographic camera	A camera intended to measure and display differences in temperature, usually shown by colour differences, in humans or objects. Differences in temperature may be used for examination and diagnosis applications (e.g., in skin conditions, vascular disorders, or breast malignancies). This device may be stand-alone or part of a thermographic system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391536710002	GS1