FDA.reportPublic FDA data

Medistim System Activation Card

Primary DI
07070554104243
Brand
Medistim System Activation Card
Company
Medistim ASA
Model
CV000445
Catalog number
CV000445
Published
2016-09-23
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
DPWFlowmeter, Blood, Cardiovascular
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102595000MEDISTIM VERIQC SYSTEMMedi-Stim Asa2010-12-27DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07070554104243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07070554104243070705541042437070554104243

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
519521751
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
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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06903053124492Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
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06903053124591Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
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