CPMX1
- Primary DI
- G247CPMX10
- Brand
- CPMX1
- Company
- Compremium AG
- Model
- 1
- Device description
- The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility.The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure.Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
- Published
- 2025-05-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| LXC | Monitor, Pressure, Intracompartmental |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXC | Monitor, Pressure, Intracompartmental | Unknown | U |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K223509 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| G247CPMX12 | Package | HIBCC | 1 | In Commercial Distribution |
| G247CPMX10 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Compartmental-pressure monitoring system, reusable | An assembly of devices designed to measure and display, periodically or continuously, the interstitial pressure in a closed fascial compartment of muscle. It typically consists of a battery-powered, hand-held, pressure-measuring instrument with a display and connected devices used to access the muscle compartment (e.g., transducing probe, extension cable). It is intended to assess chronic and/or acute compartmental syndrome, a condition of increased intra-compartmental pressures from swelling within muscle compartments and tendon sheaths due to trauma. This is a reusable device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Humidity | 20 Percent (%) Relative Humidity | 80 Percent (%) Relative Humidity | |
| Storage Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Storage Environment Temperature | -10 Degrees Celsius | 50 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +41585800878 | info@compremium.ch |
Regulatory Flags#
- DUNS number
- 485869031
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true
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