I-DIALCO INC.

Matched from indexed company URL: I-Dialco Inc

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3015472042	3015472042	I-DIALCO INC.	1	N	2026-01-01	2455 Cawthra Road, Unit 23 Mississauga Ontario CA L5A 3P1

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
229606	1813943100	K193005	DIMI RRT System	KDI	2020-08-28
229606	1254631904	K170790	SAM CRRT Unit, SAM Cassette CRRT	KDI	2017-12-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KDI	3	2020-08-28

GUDID#

DIMI RRT SYSTEM - The DIMI RRT System 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 DIMI RRT System has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
I-Dialco Inc
2026-05-05
SAMI RRT Unit - 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.
I-Dialco Inc
2025-01-31
SAMI Cassette - 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.
I-Dialco Inc
2024-11-05