Home GUDID B173SA40000 SAMI RRT Cassette
Primary DI B173SA40000
Brand SAMI RRT Cassette
Company Spectral Medical Inc
Model SA-400-00
Catalog number SA-400-00
Device description The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Published 2018-03-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true 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 B173SA40000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Haemodialysis blood tubing set, single-use A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 30 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 true Serial number false Manufacturing date on label true Expiration date on label true 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 B173SMC200 Cassette CRRT SM-200-001 SM-200-001 2018-03-05 B173SMF200 Cassette Hemofiltration SM-200-003 SM-200-003 2019-02-22 B173SM001 SAMI CRRT Unit SM-100-003 SM-100-003 2018-02-22
Other Devices Sharing Product Codes# 
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