Guardian Supporter

Basic Information

• Brand Name: Guardian Supporter
• Primary DI: 08809818038029
• Version / Model: GKC-XL
• Company Name: BM KOREA CO., LTD
• Labeler DUNS: 557799209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-20
• Public Version: 1
• Public Version Date: 2025-03-28
• Public Version Status: New
• Public Device Record Key: 6c8e7fd4-80e2-4c53-92a7-3bf694172f62

Device Description

"This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that do not provide support or reinforcement."

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: Yes
• Has Serial Number: No
• 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
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64398	Thoracic cage orthosis force meter	An electronic device designed to measure the force on the compression plate of a thoracic cage orthosis when worn by a patient, or to estimate thoracic elasticity prior to applying a thoracic cage orthosis. These measurements are used to facilitate decisions about the modification of custom treatment parameters. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809818038029	GS1

Device Sizes

Type	Value	Unit	Text
Length	560	Millimeter
Width	430	Millimeter