Plexus

Primary DI
04897089070019
Brand
Plexus
Company
ALLEVA MEDICAL LIMITED
Model
RP100
Catalog number
MI329-0001
Device description
The Plexus RP100 Portable DVT Prevention Therapy Device is a single-patient, portable, rechargeable, battery-powered, electronic device designed to stimulate blood flow and increase venous flow velocity by providing a defined pattern of intermittent pressure. The device consists of a hard-plastic outer casing (containing the electronics and pump unit) attached to a soft pressure garment sleeve with an internal air bladder. The Plexus RP100 has one therapy mode that provides a preset pattern of intermittent pressure to the lower leg. To use the device, the patient wraps the pressure garment around his/her calf tightly. When the device is turned on, air flows from the air pump into the air bladder inside the pressure sleeve, providing intermittent pneumatic pressure.
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K191107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191107000PlexusAlleva Medical (D.G), Ltd.2019-08-27JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897089070016PackageGS11In Commercial Distribution
24897089070013PackageGS110In Commercial Distribution
04897089070019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489708907001614897089070016
2489708907001324897089070013
04897089070019048970890700194897089070019

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, single-useA non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. 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. This is a single-use device.

Regulatory Flags#

DUNS number
669361099
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897089070088ExtriCAREST390-0002EC2400-MN-E2026-03-05
04897089070101ExtriCAREST392-00022026-03-05
14897089070085ExtriCAREST390-0002EC2400-MN-E2026-03-05
14897089070108ExtriCAREST392-00022026-03-05
04897089070682ExtriCAREST407-0005EC-FOAM-M-E2026-03-02
04897089070330ExtricareST396-0003EC-FOAM-S-F2026-03-02
04897089070446ExtricareST407-0003EC-FOAM-M-F2026-03-02
14897089070689ExtriCAREST407-0005EC-FOAM-M-E2026-03-02
14897089070016PlexusRP100MI329-00012026-01-14
04897089070163ExtriCARE EC-DOMEST4012025-12-03
04897089070200ExtricareST404-0001EC2400-Y-E2025-12-03
14897089070160ExtriCARE EC-DOMEST4012025-12-03
14897089070207ExtricareST404-0001EC2400-Y-E2025-12-03
04897089070996VideST425-00012025-11-03
04897089071498VideST424-0001ST424-00012025-11-03
04897089070217ExtriCAREST403-0001EC-DRAPE2023-12-28
04897089070361ExtriCAREMI423-0001EC3000-100C2023-12-28
04897089070378ExtriCAREMI424-0001EC3000-400C2023-12-28
04897089070477ExtriCAREMI425-0001EC1000-CAN2023-12-28
14897089070214ExtriCAREST403-0001EC-DRAPE2023-12-28

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