SmartNeedle® monitor
GUDID M206720000
Vascular Solutions, Inc.
Noninvasive vascular ultrasound system, battery-powered| Primary Device ID | M206720000 |
| NIH Device Record Key | a5656739-3f2a-464a-bdb2-24bbb1f93e11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartNeedle® monitor |
| Version Model Number | 72000 |
| Company DUNS | 008999906 |
| Company Name | Vascular Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M206720000 [Primary] |
FDA Product Code
| ITX | Transducer, Ultrasonic, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by Vascular Solutions, Inc.
| M20677101 - Vascular Solutions Custom Access Kit | 2023-06-09 |
| M20677141 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677181 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677191 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677201 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677211 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677221 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
| M20677231 - Vascular Solutions Custom Access Kit | 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following |
Trademark Results [SmartNeedle]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTNEEDLE 87066522 5238160 Live/Registered |
Smartneedle.inc 2016-06-09 |
 SMARTNEEDLE 86566638 not registered Dead/Abandoned |
Diagnostic Biochips, Inc. 2015-03-17 |
 SMARTNEEDLE 78837281 3274740 Dead/Cancelled |
SMARTNEEDLE.INC 2006-03-14 |
 SMARTNEEDLE 75620674 2568826 Live/Registered |
TELEFLEX INNOVATIONS S.Ã R.L. 1999-01-13 |
 SMARTNEEDLE 74094959 1690010 Dead/Cancelled |
Advanced Cardiovascular Systems, Inc. 1990-09-10 |
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