SAMI RRT

Primary DI
B815SA100010
Brand
SAMI RRT
Company
Dialco Medical Inc
Model
SA-100-01
Catalog number
SA-100-01
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 of 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.
Published
2019-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B815SA100010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system, institutionalAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure87 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18884264264gguadagni@dialco.ca

Regulatory Flags#

DUNS number
203940515
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B815SM1000030SAMI RRT SystemSM-100-003SM-100-0032021-02-12
B815SM2000030SAMI Hemofiltration CassetteSM-200-003SM-200-0032021-02-12
B815DI400000DIMI RRT CassetteDI-400-00DI-400-002020-10-26
B815DM850000DIMI RRT SystemDM-850-00DM-850-002020-09-22
B815SA300000SAMI Hemofiltration CassetteSA-300-00SA-300-002019-12-09
B815SA400000SAMI RRT CassetteSA-400-00SA-400-002019-12-09

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