FDA.reportPublic FDA data

Transonic

Primary DI
00877466000437
Brand
Transonic
Company
TRANSONIC SYSTEMS INC.
Model
HD03
Published
2020-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQSSystem, Hemodialysis, Access Recirculation Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQSSystem, Hemodialysis, Access Recirculation MonitoringGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960817000HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)Transonic Systems, Inc.1997-02-11MQS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877466000437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877466000437008774660004378774660004370877466000437

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
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
08774660001463TransonicH16AUL-52016-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00861858000310PhySoftAMSPHYSICIAN SOFTWARE SYSTEMS, LLCMQS2026-05-27
00860005737512Smart Anemia Manager (SAM)Dosis Inc.MQS2021-03-09
00877466000468TransonicTRANSONIC SYSTEMS INC.MQS2020-10-01
00877466000451TransonicTRANSONIC SYSTEMS INC.MQS2020-10-01
00877466005791TransonicTRANSONIC SYSTEMS INC.MQS2020-10-01
00861858000303PhySoft AMSPHYSICIAN SOFTWARE SYSTEMS, LLCMQS2016-09-26
08774660000466TransonicTRANSONIC SYSTEMS INC.MQS2016-04-28
08774660000473TransonicTRANSONIC SYSTEMS INC.MQS2016-04-28
08774660005799TransonicTRANSONIC SYSTEMS INC.MQS2016-04-28
08774660005805TransonicTRANSONIC SYSTEMS INC.MQS2016-04-28
08774660000428TransonicTRANSONIC SYSTEMS INC.MQS2016-04-21
08774660000435TransonicTRANSONIC SYSTEMS INC.MQS2016-04-21
08774660000442TransonicTRANSONIC SYSTEMS INC.MQS2016-04-21
08774660000459TransonicTRANSONIC SYSTEMS INC.MQS2016-04-21