Plexus MI329-0001

GUDID 14897089070016

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.

ALLEVA MEDICAL LIMITED

Multi-chamber venous compression system garment, single-use

• Primary Device ID: 14897089070016
• NIH Device Record Key: 5942e141-cd72-42d0-be06-a148b5dc624c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plexus
• Version Model Number: RP100
• Catalog Number: MI329-0001
• Company DUNS: 669361099
• Company Name: ALLEVA MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897089070019 [Primary]
GS1	14897089070016 [Package]; Contains: 04897089070019; Package: Inner Box [1 Units]; In Commercial Distribution
GS1	24897089070013 [Package]; Package: Outer carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191107

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-22
• Device Publish Date: 2026-01-14

Devices Manufactured by ALLEVA MEDICAL LIMITED

• 14897089070085 - ExtriCARE: 2026-03-13 Extricare Mini Oval Dressing
• 14897089070108 - ExtriCARE: 2026-03-13 Negative Pressure Wound Therapy Bandage - Large Oval with Tubing Set
• 04897089070330 - Extricare: 2026-03-10 Extricare Negative Pressure Wound Therapy Foam Kit - Small, with 5-feet Suction Tubing
• 04897089070446 - Extricare: 2026-03-10 Extricare Negative Pressure Wound Therapy Foam Kit - Medium, with 5-feet Suction Tubing
• 14897089070689 - ExtriCARE: 2026-03-10 Extricare Negative Pressure Wound Therapy Foam Kit - Medium with Tubing Set
• 14897089070016 - Plexus: 2026-01-22The 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.
• 14897089070016 - Plexus: 2026-01-22 The Plexus RP100 Portable DVT Prevention Therapy Device is a single-patient, portable, rechargeable, battery-powered, electronic
• 14897089070160 - ExtriCARE: 2025-12-11 ExtriCARE Suction Dome Set with Tubing
• 14897089070207 - Extricare: 2025-12-11 Extricare Y-Connectors, blank label