FDA.reportPublic FDA data

Transonic

Primary DI
00877466001328
Brand
Transonic
Company
TRANSONIC SYSTEMS INC.
Model
HQF8AU
Published
2020-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872048000TRANSONIC FLOWMETERTransonic Systems, Inc.1988-06-21DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877466001328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877466001328008774660013288774660013280877466001328

GMDN Terms#

Term, Definition table
TermDefinition
Invasive vascular ultrasound systemA mains electricity (AC-powered) device assembly designed to invasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) using ultrasound/Doppler/transit time technology during procedures involving vascular surgery. It may also provide additional measurements (e.g., blood pressure, vascular resistance). It consists of a mobile (on wheels) control unit with graphical user-interface, typically placed outside the sterile field; and an attached, reusable, sterilizable probe intended to be used within the body (invasive) but not within the lumen of the blood vessel. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Hydrogen Peroxide""]"
Ethylene Oxide;Hydrogen Peroxide

Regulatory Flags#

DUNS number
101317451
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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
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00888937027815CooperSurgical® Coopersurgical, Inc.DPW2026-04-01
00888937027839CooperSurgical® Coopersurgical, Inc.DPW2026-04-01
00813079022664VascuChek TransceiverREMINGTON MEDICAL, INC.DPW2025-11-27
00813079022671VascuChek Speaker DockREMINGTON MEDICAL, INC.DPW2025-11-27
00813079022688VascuChek KitREMINGTON MEDICAL, INC.DPW2025-11-27
00888937027822CooperSurgical® Coopersurgical, Inc.DPW2025-09-25
00627987360158Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
10627987360155Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
07070554102690Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
07070554103611Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
00813079022619VascuChek Surgical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022657VascuChek Clinical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
10813079022616VascuChek Surgical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022626VascuChek TransceiverREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022633VascuChek ChargerREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022640VascuChek KitREMINGTON MEDICAL, INC.DPW2024-08-23
10813079022654VascuChek Clinical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
07070554103444Medistim MiraQ Vascular SystemMedistim ASADPW2024-04-12
00817122020560VTI 8MHz TQI 2.0 Doppler TransceiverVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00817122020577Footswitch, MutingVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00817122020584Pole MountVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00627987360134Reprocess FloPatch1929803 Ontario CorpDPW2023-05-08
10627987360131Reprocess FloPatch1929803 Ontario CorpDPW2023-05-08
00627987360141Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
10627987360148Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
00627987360110Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
10627987360117Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
00627987360127Acrylate Adhesive Strap1929803 Ontario CorpDPW2022-06-17
10080196734290MedlineMEDLINE INDUSTRIES, INC.DPW2022-03-04