Home GUDID B173SM001 SAMI CRRT Unit
Primary DI B173SM001
Brand SAMI CRRT Unit
Company Spectral Medical Inc
Model SM-100-003
Catalog number SM-100-003
Device description The SAMI CRRT Unit is a software controlled device that performs the following functions: - Primes the CRRT disposable cassette automatically. - Pumps
Published 2018-02-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B173SM001 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 87 KiloPascal 106 KiloPascal Storage Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Storage Environment Temperature 15 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 248909939 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B173EAASTNA0 Endotoxin Activity Assay (EAA) EAAST-NA EAAST-NA 2018-01-09 B173840070 Smart Line TL Tube Luminometer 84007 84007 2019-03-14 B17384018010 Sirius 2 Tube Luminometer 84018-01 8401801 2025-03-21 B173EAAST200 Endotoxin Activity Assay (EAA) EAAST-20 EAAST-20 2021-02-18 B173SA400000 SAMI RRT Cassette SA-400-00 SA-400-00 2018-03-05 B173SM1000030 SAMI RRT SM-100-003 SM-100-003 2018-02-22 B173SM2000030 SAMI Hemofiltration Cassette SM-200-003 SM-200-003 2019-02-22 B173SA40000 SAMI RRT Cassette SA-400-00 SA-400-00 2018-03-05 B173SMC200 Cassette CRRT SM-200-001 SM-200-001 2018-03-05 B173SMF200 Cassette Hemofiltration SM-200-003 SM-200-003 2019-02-22
Other Devices Sharing Product Codes# 
spectraldx.com