SmartNeedle® vascular access system
GUDID M206780501
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| Primary Device ID | M206780501 |
| NIH Device Record Key | b3a265f9-31d8-4fd4-9786-8c152430d477 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartNeedle® vascular access system |
| Version Model Number | 78050 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
Device Dimensions
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
| Needle Gauge | 18 Gauge |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M206780500 [Primary] |
| HIBCC | M206780501 [Package] Contains: M206780500 Package: Box [10 Units] In Commercial Distribution |
FDA Product Code
| ITX | Transducer, Ultrasonic, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2016-09-06 |
On-Brand Devices [SmartNeedle® vascular access system]
| M206781301 | Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves |
| M206781201 | Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves |
| M206781101 | Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves |
| M206780601 | Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves |
| M206780501 | Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves |
| M206780400 | Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous ves |
| M206780300 | 78030 |
| M206675030 | 67503 |
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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