SAMI RRT - The SAMI RRT Unit is a software controlled device - Dialco Medical Inc

Duns Number:203940515

Device Description: The SAMI RRT Unit is a software controlled device that performs the following functions: - 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.

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More Product Details

Catalog Number

SA-100-01

Brand Name

SAMI RRT

Version/Model Number

SA-100-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Device Record Status

Public Device Record Key

b6838976-1d11-4a93-a35f-19b1d5524a6d

Public Version Date

February 15, 2021

Public Version Number

2

DI Record Publish Date

December 09, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIALCO MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7