FDA.reportPublic FDA data

SAMI RRT

Primary DI
B173SM1000030
Brand
SAMI RRT
Company
Spectral Medical Inc
Model
SM-100-003
Catalog number
SM-100-003
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 therapyin 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 to 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.
Published
2018-02-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B173SM1000030PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure87 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18884264264gguadagni@spectraldx.com

Regulatory Flags#

DUNS number
248909939
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B173EAASTNA0Endotoxin Activity Assay (EAA)EAAST-NAEAAST-NA2018-01-09
B173840070Smart Line TL Tube Luminometer84007840072019-03-14
B17384018010Sirius 2 Tube Luminometer84018-0184018012025-03-21
B173EAAST200Endotoxin Activity Assay (EAA)EAAST-20EAAST-202021-02-18
B173SA400000SAMI RRT CassetteSA-400-00SA-400-002018-03-05
B173SM2000030SAMI Hemofiltration CassetteSM-200-003SM-200-0032019-02-22
B173SA40000SAMI RRT CassetteSA-400-00SA-400-002018-03-05
B173SMC200Cassette CRRTSM-200-001SM-200-0012018-03-05
B173SMF200Cassette HemofiltrationSM-200-003SM-200-0032019-02-22
B173SM001SAMI CRRT UnitSM-100-003SM-100-0032018-02-22

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