Identity
- Trade Name
- DIMI RRT System FDA UDI
- Generic Name
- Haemodialysis system, institutional/home-use FDA UDI
- Device Name
- The DIMI RRT System is a software controlled device that performs the following functions: - Primes the disposable cassette automatically, - Pumps blood through the blood flow path of the disposable cassette, - Delivers anticoagulant into the blood flow path, - Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use, - Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies, - Controls the patient fluid removal or plasma loss according to the therapy in use, - Monitors the system and alerts the operator of abnormal situations through alarms. The DIMI RRT System has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set. FDA UDI
- Model / Reference
- DM-850-00 FDA UDI
- Description
- The DIMI RRT System is a software controlled device that performs the following functions: - Primes the disposable cassette automatically, - Pumps blood through the blood flow path of the disposable cassette, - Delivers anticoagulant into the blood flow path, - Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use, - Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies, - Controls the patient fluid removal or plasma loss according to the therapy in use, - Monitors the system and alerts the operator of abnormal situations through alarms. The DIMI RRT System has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set. FDA UDI
Identifiers
- Catalog Number
- DM-850-00 FDA UDI
- Primary DI / UDI-DI
- B815DM850000 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemodialysis system, institutional/home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haemodialysis system, institutional/home-use
DIMI RRT System by Dialco Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system, institutional/home-use.
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- NXView Touch Monitor — NxStage Medical, Inc. · Class II
- Moda-flx Hemodialysis System — Diality, Inc. · Class II
- NXSTAGE SYSTEM ONE — NxStage Medical, Inc. · Class II
- 2008® Series Hemodialysis Machines — Fresenius Usa, Inc. · Class II
- NXSTAGE SYSTEM ONE — NxStage Medical, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dialco Medical Inc
Sources (1)
- FDA UDI 91c224f8-0be5-483f-bbde-3127b83add36 36 fields · synced Jun 6, 2026