FDA.reportPublic FDA data

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

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
B173SM001PrimaryHIBCC0

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
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 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
B173SM1000030SAMI RRTSM-100-003SM-100-0032018-02-22
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

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07332414124731TherMaxVantive Health GmbHKDI2026-10-21
07332414126018PrismaxVantive Health GmbHKDI2026-10-21
04039361273590multiFluxFresenius Medical Care Holdings, Inc.KDI2026-09-29
04039361273613multiFluxFresenius Medical Care Holdings, Inc.KDI2026-09-29
07332414202309TherMaxVantive Health GmbHKDI2026-07-06
08056992333536HEMOCOR HPH MINI - PEDIATRICMEDICA SPAKDI2026-07-06
07332414200183RevaclearVantive Health GmbHKDI2026-05-29
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08056992333574HPH-1000 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333581HPH-1400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333598HPH-400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333604HPH-1000TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333611HPH-1400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333628HPH JUNIORMEDICA SPAKDI2026-04-01
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