AccessGUDID - DEVICE: SAMI RRT System (B815SM1000030)

GUDID

Device Identifier (DI) Information

Brand Name: SAMI RRT System
Version or Model: SM-100-003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SM-100-003
Company Name: Dialco Medical Inc

Primary DI Number: B815SM1000030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203940515 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: da7ffc8e-5275-497c-929f-742907d04901
Public Version Date: February 22, 2021
Public Version Number: 1
DI Record Publish Date: February 12, 2021