SAMI RRT
Basic Information
- Brand Name
- SAMI RRT
- Primary DI
- B173SM1000030
- Version / Model
- SM-100-003
- Catalog Number
- SM-100-003
- Company Name
- Spectral Medical Inc
- Labeler DUNS
- 248909939
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-22
- Public Version
- 7
- Public Version Date
- 2021-02-23
- Public Version Status
- Update
- Public Device Record Key
- 46aced0a-6fa4-4248-a9bd-65d1d1b3898b
- Distribution End Date
- 2021-02-22
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58130 | Haemodialysis system, institutional | An assembly of mains electricity (AC-powered) devices intended to be used to perform patient haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes, by trained professionals in a healthcare facility. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. It typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B173SM1000030 | HIBCC |
Customer Contacts
- Phone
- 18884264264
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 87 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius