SmartNeedle® vascular access system

GUDID M206781101

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.

Vascular Solutions, Inc.

Noninvasive vascular ultrasound system, battery-powered Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system
Primary Device IDM206781101
NIH Device Record Keyc91eefa9-7f2d-4757-b5b2-a9d74ddedd19
Commercial Distribution Discontinuation2020-03-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSmartNeedle® vascular access system
Version Model Number78110
Company DUNS008999906
Company NameVascular Solutions, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com

Device Dimensions

Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge
Needle Gauge26 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM206781100 [Primary]
HIBCCM206781101 [Package]
Contains: M206781100
Package: Box [10 Units]
Discontinued: 2020-03-06
Not in Commercial Distribution

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-24
Device Publish Date2016-09-06

On-Brand Devices [SmartNeedle® vascular access system]

M206781301Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves
M206781201Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves
M206781101Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves
M206780601Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves
M206780501Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves
M206780400Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves
M20678030078030
M20667503067503

Trademark Results [SmartNeedle]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMARTNEEDLE
SMARTNEEDLE
87066522 5238160 Live/Registered
Smartneedle.inc
2016-06-09
SMARTNEEDLE
SMARTNEEDLE
86566638 not registered Dead/Abandoned
Diagnostic Biochips, Inc.
2015-03-17
SMARTNEEDLE
SMARTNEEDLE
78837281 3274740 Dead/Cancelled
SMARTNEEDLE.INC
2006-03-14
SMARTNEEDLE
SMARTNEEDLE
75620674 2568826 Live/Registered
TELEFLEX INNOVATIONS S.À R.L.
1999-01-13
SMARTNEEDLE
SMARTNEEDLE
74094959 1690010 Dead/Cancelled
Advanced Cardiovascular Systems, Inc.
1990-09-10

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