AccessGUDID - DEVICE: CPMX1 (G247CPMX10)

GUDID

Device Identifier (DI) Information

Brand Name: CPMX1
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Compremium AG

Primary DI Number: G247CPMX10
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 485869031 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58297	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXC	Monitor, Pressure, Intracompartmental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223509	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8652e20f-4dff-4f51-aaa3-3234714b1f91
Public Version Date: May 27, 2025
Public Version Number: 1
DI Record Publish Date: May 19, 2025