201Max Calibrated device

Basic Information

• Brand Name: 201Max Calibrated device
• Primary DI: 07290105870155
• Version / Model: 201Max
• Catalog Number: L1000063
• Company Name: MEGO afek Agricultural Cooperative Society Ltd
• Labeler DUNS: 514658082
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-24
• Public Version: 2
• Public Version Date: 2023-06-15
• Public Version Status: Update
• Public Device Record Key: 0b03a81e-2bbe-4304-9103-2eb8c0fd80dd
• Distribution End Date: 2023-06-14

Device Description

Lympha Press® 201Max™ is a calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump". The Lympha Press® 201Max™ system consists of: • The console (sometimes called "compressor" or "pump"), supplying air at fixed pressures to a compression garment that is worn over the area to be treated. • Hoses that transfer the air from the console to each of the cells in the compression garment. • The compression garment (sometimes called a "sleeve"), fastened around the area to be treated. Each garment contains up to 24 overlapping air cells. These air cells are filled with air from the console in sequence, applying a compressive massage. Once the entire limb has been compressed, Lympha Press® 201Max™ releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete. The compress-and-release massage action of Lympha Press® 201Max™ stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
JOW	Sleeve, Limb, Compressible	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44785	Sequential venous compression system pump	An electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the sequential inflation and deflation of the multi-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290105870155	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100677	000