Identity
- Trade Name
- SAMI RRT FDA UDI
- Generic Name
- Haemodialysis system, institutional FDA UDI
- Device Name
- The SAMI RRT Unit 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 to abnormal situations through alarms. The SAMI RRT Unit 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
- SM-100-003 FDA UDI
- Description
- The SAMI RRT Unit 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 to abnormal situations through alarms. The SAMI RRT Unit 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
- SM-100-003 FDA UDI
- Primary DI / UDI-DI
- B173SM1000030 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemodialysis system, institutional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 FDA UDI
- Commercial Distribution
- Not 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
Sami Rrt by Spectral Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Spectral Medical Inc
Sources (1)
- FDA UDI 46aced0a-6fa4-4248-a9bd-65d1d1b3898b 37 fields · synced Jun 1, 2026