PCD-51 731A (US) - White

Basic Information

• Brand Name: PCD-51 731A (US) - White
• Primary DI: 07290105879332
• Version / Model: 731A
• Catalog Number: L10015G1
• Company Name: MEGO afek Agricultural Cooperative Society Ltd
• Labeler DUNS: 514658082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-24
• Public Version: 1
• Public Version Date: 2020-01-01
• Public Version Status: New
• Public Device Record Key: 22bc4361-1aae-42c0-a882-4022d9e3e24b

Device Description

The PCD-51™ system is a sequential pneumatic compression therapy system for treatment and management of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump". The PCD-51™ system consists of: • The console (sometimes called "compressor" or "pump"). It supplies air at regulated pressure to a compression garment that is worn around the area to be treated. • Hoses that transfer the air from the console to each of the chambers in the compression garment. • The compression garment is fastened around the area to be treated. Each garment contains 4 overlapping air chambers. These chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the console 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 the PCD-51™ system 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 lymphatic vessels 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: MR Unsafe
• 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	07290105879332	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121962	000