FDA.reportPublic FDA data

Transonic

Primary DI
00877466000468
Brand
Transonic
Company
TRANSONIC SYSTEMS INC.
Model
ADT1010-40
Published
2020-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K021571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021571000TRANSONIC FLOW-QC SET MODEL ADT1010Transonic Systems, Inc.2002-08-12MQS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877466000468PrimaryGS10
00877466005791Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877466000468008774660004688774660004680877466000468
00877466005791008774660057918774660057910877466005791

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.

Regulatory Flags#

DUNS number
101317451
Device count
40
Lot or batch
true
Expiration 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
00861858000310PhySoftAMSPHYSICIAN SOFTWARE SYSTEMS, LLCMQS2026-05-27
00860005737512Smart Anemia Manager (SAM)Dosis Inc.MQS2021-03-09
00877466000437TransonicTRANSONIC 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