Home GUDID M206780600 SmartNeedle® vascular access system
Primary DI M206780600
Brand SmartNeedle® vascular access system
Company Vascular Solutions, Inc.
Model 78060
Device description Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Published 2016-09-06
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M206780601 Package HIBCC 5 Not in Commercial Distribution M206780600 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Noninvasive vascular ultrasound system An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.
Device Sizes# Type, Value, Unit table Type Value Unit Needle Gauge 18 Gauge
Regulatory Flags# DUNS number 008999906 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M20655660 TrapLiner™ catheter 5566 2017-02-07 M20655680 TrapLiner™ catheter 5568 2017-02-07 M20655670 TrapLiner™ catheter 5567 2017-02-07 M20655690 GuideLiner® V3 catheter 5569 2016-09-05 M20655700 GuideLiner® V3 catheter 5570 2016-09-05 M20655710 GuideLiner® V3 catheter 5571 2016-09-05 M20655720 GuideLiner® V3 catheter 5572 2016-09-05 M20655730 GuideLiner® V3 catheter 5573 2016-09-05 M20656210 Turnpike® Gold catheter 5621 2016-09-05 M20656220 Turnpike® Gold catheter 5622 2016-09-05 M20656380 Turnpike® LP catheter 5638 2016-09-05 M20656390 Turnpike® LP catheter 5639 2016-09-05 M20656400 Turnpike® Spiral catheter 5640 2016-09-05 M20656410 Turnpike® Spiral catheter 5641 2016-09-05 M20656420 Turnpike® catheter 5642 2016-09-05 M20656430 Turnpike® catheter 5643 2016-09-05 M20654700 GuideLiner® Navigation™ catheter 5470 2016-09-05 M20654710 GuideLiner® Navigation™ catheter 5471 2016-09-05 M20654720 GuideLiner® Navigation™ catheter 5472 2016-09-05 M20654730 GuideLiner® Navigation™ catheter 5473 2016-09-05
Other Devices Sharing Product Codes# 
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