Plexus

Primary DI
14897089070016
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
669361099
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04897089070019PlexusRP100MI329-00012026-01-14
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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