Plexus
Basic Information
- Brand Name
- Plexus
- Primary DI
- 04897089070019
- Version / Model
- RP100
- Catalog Number
- MI329-0001
- Company Name
- ALLEVA MEDICAL LIMITED
- Labeler DUNS
- 669361099
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-14
- Public Version
- 1
- Public Version Date
- 2026-01-22
- Public Version Status
- New
- Public Device Record Key
- 5942e141-cd72-42d0-be06-a148b5dc624c
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | Cardiovascular | 870.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44762 | Multi-chamber venous compression system garment, single-use | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14897089070016 | GS1 | Inner Box | 1 | In Commercial Distribution | |
| Primary | 04897089070019 | GS1 | ||||
| Package | 24897089070013 | GS1 | Outer carton | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191107 | 000 |