FDA.reportPublic FDA data

Clarifi Imaging System

Primary DI
00859806007023
Brand
Clarifi Imaging System
Company
MODULATED IMAGING INC.
Model
Clarifi
Device description
Tissue Saturation Oximeter
Published
2018-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859806007023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859806007023008598060070238598060070230859806007023

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeterA mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603130928
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859806007016Ox-ImagerCS2018-01-19
00859806007030Clarifi Cart0859806007032019-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMUD2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMUD2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMUD2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMUD2026-10-04
00885403523437HemoSphere AltaBecton, Dickinson And CompanyMUD2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyMUD2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyMUD2026-08-06
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyMUD2026-04-15
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCMUD2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCMUD2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCMUD2025-09-10
00690103219616ForeSight IQEdwards Lifesciences LLCMUD2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCMUD2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCMUD2025-07-11
10884521845985INVOSCovidien LPMUD2025-07-03
00690103217957HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
10884521845039INVOSCovidien LPMUD2025-02-08
20884521845036INVOSCovidien LPMUD2025-02-08
00690103218879HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103211313ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211320ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211337ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211318ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211325ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211332ForeSightEdwards Lifesciences LLCMUD2024-08-26
10884521701243INVOSCovidien LPMUD2024-04-14
10884521557048INVOSCovidien LPMUD2024-04-14