PCD-51 731A (US) - White

Primary DI
07290105879332
Brand
PCD-51 731A (US) - White
Company
MEGO afek Agricultural Cooperative Society Ltd
Model
731A
Catalog number
L10015G1
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."
Published
2019-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121962000PRACTICAL COMPRESSION DEVICE (PCD) 901A&901BMego Afek AC , Ltd.2012-10-19JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290105879332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290105879332072901058793327290105879332

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression system inflatorAn electrically-powered device intended to be 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 applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7327929677info@lympha-press.com
8885967421info@patriotmedical.com

Regulatory Flags#

DUNS number
514658082
Device count
1
Serial number
true
Manufacturing date on label
true

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