12 MedaFit

Basic Information

• Brand Name: 12 MedaFit
• Primary DI: 00745129306601
• Version / Model: 12BK
• Catalog Number: 1203-BKS-L
• Company Name: SIGVARIS INC
• Labeler DUNS: 189738719
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-30
• Public Version: 1
• Public Version Date: 2024-02-07
• Public Version Status: New
• Public Device Record Key: be86233f-6bd6-48bb-a71e-f42b3e2f8171

Device Description

Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.

Device Characteristics

• Single Use: Yes
• 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
MDR	Binder, Medical, Therapeutic	General Hospital	880.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58993	General-purpose medical foam padding, single-use	A roll, sheet or preformed shape of synthetic latex foam material [e.g., styrene-butadiene rubber (SBR)] intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.	No	Active
59049	General-purpose medical fibre padding	A roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00745129306601	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Pressure,15-20 mmHg