FDA.reportPublic FDA data

Transonic

Primary DI
08774660000381
Brand
Transonic
Company
TRANSONIC SYSTEMS INC.
Model
H6FX
Published
2016-04-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DXGComputer, Diagnostic, Pre-Programmed, Single-Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K134051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K134051000TRANSONIC ELSA SYSTEMTransonic Systems, Inc.2015-01-29DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08774660000381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08774660000381087746600003818774660000381

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, line-poweredA mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101317451
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877466000437TransonicHD032020-10-01
00877466002141TransonicHQD3FMV2020-10-08
00877466001182TransonicHQD24AU2020-10-08
00877466001762TransonicHQD2FME2020-10-08
00877466001779TransonicHQD3FME2020-10-08
00877466001786TransonicHQD4FME2020-10-08
00877466001809TransonicHQD8FME2020-10-08
08774660000244TransonicADT1001-102016-04-28
08774660000251TransonicADT1002-102016-04-28
08774660000268TransonicADT1004-102016-04-28
08774660000336TransonicHCS3011-52016-04-28
08774660000343TransonicHCS3012-52016-04-28
08774660000350TransonicHCS3021-52016-04-28
08774660000367TransonicHCS3002-52016-04-28
08774660000466TransonicADT1010-402016-04-28
08774660000473TransonicADT1018-402016-04-28
08774660001425TransonicH8AUL-52016-04-28
08774660001432TransonicH10AUL-52016-04-28
08774660001449TransonicH12AUL-52016-04-28
08774660001456TransonicH14AUL-52016-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850044487110Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487127Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487134Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDXG2026-04-15
00198953049181NAGE Healthcare Finland OyDXG2026-01-05
00198953066560NAGE Healthcare Finland OyDXG2026-01-05
07290020154101BB-613W Wrist-MonitorBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
07290020154309BB-613 H@H kitBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
00843997001823LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997002882LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017428LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017435LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017190LiDCOMASIMO CORPORATIONDXG2024-07-26
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2024-07-10
00850044487011Retia MedicalRETIA MEDICAL, LLCDXG2024-02-01
17290013030044StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
27290013030041StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
47290013030045StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
07290013030047StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
77290013030046StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDXG2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDXG2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDXG2023-04-19
00195278524089NAGE Healthcare Finland OyDXG2023-04-19
00850044487004Retia MedicalRETIA MEDICAL, LLCDXG2023-02-21
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2022-06-09