Foot Compression Wrap Large

Basic Information

• Brand Name: Foot Compression Wrap Large
• Primary DI: 00856525007976
• Version / Model: MW5360
• Catalog Number: FCW-300
• Company Name: SUN SCIENTIFIC, INC.
• Labeler DUNS: 609397224
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-10
• Public Version: 1
• Public Version Date: 2023-11-20
• Public Version Status: New
• Public Device Record Key: 1848ec08-7800-4e06-9313-bf6fd7f31d51
• Distribution End Date: 2030-05-18

Device Description

Aero-Wrap™ Foot Compression Wrap is designed to provide therapeutic compression therapy, in the inpatient and outpatient setting, in the treatment of edema and lymphedema of the foot or as part of a wound treatment protocol.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
MHW	Dressing, Compression	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42811	Compression/pressure sock/stocking, reusable	A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856525007976	GS1

Customer Contacts

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