FDA.reportPublic FDA data

Medistim Vascular TTFM probe

Primary DI
07070554101174
Brand
Medistim Vascular TTFM probe
Company
Medistim ASA
Model
PV100051
Catalog number
PV100051
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992305000MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004Medi-Stim A/S1999-09-08ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07070554101174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07070554101174070705541011747070554101174

GMDN Terms#

Term, Definition table
TermDefinition
Invasive vascular ultrasound system probeA hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Liquid Chemical"", ""Hydrogen Peroxide"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

Regulatory Flags#

DUNS number
519521751
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
07070554100818Medistim QuickFIT TTFM probePS100032PS1000322016-09-15
07070554100825Medistim QuickFIT TTFM probePS100042PS1000422016-09-15
07070554100832Medistim QuickFIT TTFM probePS100052PS1000522016-09-15
07070554100849Medistim QuickFIT TTFM probePS101012PS1010122016-09-15
07070554100856Medistim QuickFIT TTFM probePS100072PS1000722016-09-15
07070554100955Medistim Vascular TTFM probePV100061PV1000612016-09-15
07070554100962Medistim Vascular TTFM probePV100062PV1000622016-09-15
07070554100979Medistim Vascular TTFM probePV100081PV1000812016-09-15
07070554100986Medistim Vascular TTFM probePV100082PV1000822016-09-15
07070554100993Medistim Vascular TTFM probePV100141PV1001412016-09-15
07070554101006Medistim QuickFIT TTFM probePS101011PS1010112016-09-15
07070554101020Medistim Vascular TTFM probePV100101PV1001012016-09-15
07070554101044Medistim Vascular TTFM probePV100121PV1001212016-09-15
07070554101051Medistim Vascular TTFM probePV100122PV1001222016-09-15
07070554101068Medistim Vascular TTFM probePV100161PV1001612016-09-15
07070554101075Medistim Vascular TTFM probePV100162PV1001622016-09-15
07070554101082Medistim Vascular TTFM probePV100142PV1001422016-09-15
07070554101112Medistim Vascular TTFM probePV101011PV1010112016-09-15
07070554101129Medistim Vascular TTFM probePV100021PV1000212016-09-15
07070554101136Medistim Vascular TTFM probePV100031PV1000312016-09-15

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Primary DI, Brand, Company table
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04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
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08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
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08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
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08056304455635MyLabE80ESAOTE SPAITX2025-07-07
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