FDA.reportPublic FDA data

Transonic

Primary DI
08774660000473
Brand
Transonic
Company
TRANSONIC SYSTEMS INC.
Model
ADT1018-40
Published
2016-04-28
Public version status
Update
Distribution status
Not 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
08774660000473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08774660000473087746600004738774660000473

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
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
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
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
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