DEVICE: Lympha Press Optimal Plus(US) BT (07290105879110)

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Device Identifier (DI) Information

Lympha Press Optimal Plus(US) BT
912
In Commercial Distribution
L10008C2-US
MEGO afek Agricultural Cooperative Society Ltd
07290105879110
GS1

1
514658082 *Terms of Use
The Lympha Press® Optimal Plus system is a multi-zone calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the "muscle pump", lipedema, and edemas caused by trauma and immobility. The Lympha Press® Optimal Plus system consists of: • The console (sometimes called "compressor" or "pump") supplies air at regulated pressures to a compression garment that is worn over the area to be treated. • Hoses 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 overlapping air chambers. These air 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 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.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44785 Sequential venous compression system inflator
An 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JOW Sleeve, Limb, Compressible
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K182003 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

bd8c93c8-0585-4e03-8375-e734fd59ede2
September 19, 2024
2
December 24, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
7327929677
info@lympha-press.com
8885967421
info@patriotmedical.com
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