Definition: A Remote Medication Management System Provides A Means For The Patient's Prescribed Medications To Be Stored In A Delivery Unit; For A Medical Provider To Remotely Schedule The Patient's Prescribed Medications; To Provide Notification To The Patient
| Device Type ID | 2704 |
| Device Name | Medication Management System, Remote |
| Physical State | A Remote Medication Management System Consists Of Three Primary Components: Control Software (clinical And Communications Software), The Medication Delivery Unit, And A Specialized Blister Package Containing The Patient's Prescribed Medications That |
| Technical Method | A Clinician Using The Clinical Software Enters The Patient's Prescribed Medication Schedule. The Patient Goes To A Pharmacy And Receives The Prescription Packaged In One Or More Blister Pack Discs. The Medication Delivery Unit Then Dispenses The Medi |
| Target Area | Intended For Delivery Of Pill Type Medication. |
| Regulation Description | Remote Medication Management System. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6315 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NZH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2704 |
| Device | Medication Management System, Remote |
| Product Code | NZH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Remote Medication Management System. |
| CFR Regulation Number | 880.6315 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INRANGE SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |