INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM
Device Facts
| Record ID | DEN060002 |
|---|---|
| Device Name | INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM |
| Applicant | Inrange Systems, Inc. |
| Product Code | NZH · General Hospital |
| Decision Date | Jun 13, 2007 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 880.6315 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A remote medication management system is a device composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended to store the patient's prescribed medications in a delivery unit, to permit a health care professional to remotely schedule the patient's prescribed medications, to notify the patient when the prescribed medications are due to be taken, to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command, and to record a history of the event for the health care professional. The system is intended for use as an aid to health care professionals in managing therapeutic regimens for patients in the home or clinic.
Special Controls
*Classification.* Class II (special controls). The special control is: The FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System.” See § 880.1(e) for availability of this guidance document.
