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Intended Use

The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.

Device Description

The VasoPress DVT Leg Garment (sterile) consists of a brushed nylon outer material bonded to a foam inner liner bonded to an inner lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The devices are terminally sterilized with Ethylene Oxide (EO) gas.

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K Number

K112838

Device Name

VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS

Manufacturer

Date Cleared

2011-11-10

(43 days)

Product Code

JOW PRO

Regulation Number

COMPRESSION THERAPY CONCEPTS

Intended Use

The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.

Device Description

The VasoPress Reprocessed DVT Leg Garment consists of a brushed nylon outer material bonded to a foam inner liner bonded to a tricot lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress Reprocessed DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The reprocessed devices are cleaned, inspected and tested, packaged and exposed to Ethylene Oxide (EO) gas wash. The VasoPress Reprocessed DVT Garments are provided non-sterile.

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K Number

K102940

Device Name

VASCOPRESS SEQUENTIAL DVT PUMP

Manufacturer

Date Cleared

2011-01-20

(108 days)

Product Code

Regulation Number

COMPRESSION THERAPY CONCEPTS

Intended Use

The VasoPress Sequential DVT Pump is an external pneumatic compression device for use with VasoPress Sequential Garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

Device Description

The VasoPress Sequential DVT Pump is an external pneumatic compression device for use with VasoPress Sequential Garments.

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K Number

K102732

Device Name

VASOGRAD DVT COMPRESSION GARMENT

Manufacturer

Date Cleared

2010-10-19

(27 days)

Product Code

Regulation Number

Intended Use

The VasoGrad DVT Compression Garment is an external pneumatic compression device for use with VasoPress DVT Pumps, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

Device Description

Not Found

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K Number

K101915

Device Name

VASOPRESS SUPREME MINI MODEL VP500DM

Manufacturer

Date Cleared

2010-08-06

(28 days)

Product Code

Regulation Number

Intended Use

The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

Device Description

VasoPress DVT Supreme Mini, Pump Model No. VP500DM

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K Number

K061814

Device Name

VASOPRESS DVT SYSTEM, MODEL VP500D

Manufacturer

Date Cleared

2006-11-30

(156 days)

Product Code

Regulation Number

Intended Use

The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

Device Description

VasoPress DVT System, Pump Model VP500D

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K Number

K061967

Device Name

SCD GARMENT, MODEL VP530

Manufacturer

Date Cleared

2006-09-25

(75 days)

Product Code

Regulation Number

Intended Use

The VasoQuential is designed to increase venous blood flow in at The Vasoquencear in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Device Description

Not Found

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K Number

K000147

Device Name

CTC DVT-1 CALF GARMENT, MODEL DVT-1

Manufacturer