SAMI RRT SA-100-01

GUDID B815SA100010

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.

Dialco Medical Inc

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• Primary Device ID: B815SA100010
• NIH Device Record Key: b6838976-1d11-4a93-a35f-19b1d5524a6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAMI RRT
• Version Model Number: SA-100-01
• Catalog Number: SA-100-01
• Company DUNS: 203940515
• Company Name: Dialco Medical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca
• Phone: 18884264264
• Email: gguadagni@dialco.ca

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 87 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B815SA100010 [Primary]

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-17
• Device Publish Date: 2019-12-09

Devices Manufactured by Dialco Medical Inc

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• B815SM2000030 - SAMI Hemofiltration Cassette: 2021-02-22 The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The packag
• B815DI400000 - DIMI RRT Cassette: 2020-11-03 The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is steril
• B815DM850000 - DIMI RRT System: 2020-09-30 The DIMI RRT System is a software controlled device that performs the following functions: - Primes the disposable cassette aut
• B815SA100010 - SAMI RRT: 2019-12-17The 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.
• B815SA100010 - SAMI RRT: 2019-12-17 The SAMI RRT Unit is a software controlled device that performs the following functions: - Primes the disposable cassette autom
• B815SA300000 - SAMI Hemofiltration Cassette: 2019-12-17 The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The packag
• B815SA400000 - SAMI RRT Cassette: 2019-12-17 The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is steril