NITREX™
GUDID 20763000185521
GW N351453 NITREX V04
EV3, INC
Peripheral vascular guidewire, manual| Primary Device ID | 20763000185521 |
| NIH Device Record Key | 81121418-a745-4713-a08a-d8e8bfec92d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NITREX™ |
| Version Model Number | N351453 |
| Company DUNS | 117446916 |
| Company Name | EV3, 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 | 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
Device Dimensions
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.89 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000185527 [Primary] |
| GS1 | 20763000185521 [Package] Contains: 00763000185527 Package: PK [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040345
FDA Product Code
| DQX | Wire, guide, catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-24 |
| Device Publish Date | 2020-08-16 |
On-Brand Devices [NITREX™]
| 20763000185644 | GW N354002 NITREX V04 |
| 20763000185637 | GW N354001 NITREX V04 |
| 20763000185620 | GW N353001 NITREX V04 |
| 20763000185613 | GW N352604 NITREX V04 |
| 20763000185606 | GW N352603 NITREX V04 |
| 20763000185590 | GW N352602 NITREX V04 |
| 20763000185583 | GW N352601 NITREX V04 |
| 20763000185576 | GW N351805 NITREX V04 |
| 20763000185569 | GW N351804 NITREX V04 |
| 20763000185552 | GW N351803 NITREX V04 |
| 20763000185545 | GW N351455 NITREX V04 |
| 20763000185538 | GW N351454 NITREX V04 |
| 20763000185521 | GW N351453 NITREX V04 |
| 20763000185514 | GW N351452 NITREX V04 |
| 20763000185507 | GW N351451 NITREX V04 |
| 20763000185491 | GW N350801 NITREX V04 |
| 20763000185484 | GW N252601 NITREX V04 |
| 20763000185477 | GW N251802 NITREX V04 |
| 20763000185460 | GW N251801 NITREX V04 |
| 20763000185453 | GW N183002 NITREX V04 |
| 20763000185446 | GW N183001 NITREX V04 |
| 20763000185439 | GW N181806 NITREX V04 |
| 20763000185422 | GW N181805 NITREX V04 |
| 20763000185415 | GW N181804 NITREX V04 |
| 20763000185408 | GW N180802 NITREX V04 |
| 20763000185392 | GW N180801 NITREX V04 |
| 20763000185385 | GW N180603 NITREX V04 |
| 20763000185378 | GW N180601 NITREX V04 |
| 20763000185361 | GW N143001 NITREX V04 |
| 20763000185354 | GW N141802 NITREX V04 |
| 20763000185347 | GW N140801 NITREX V04 |
Trademark Results [NITREX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NITREX 86226045 not registered Dead/Abandoned |
Delta Medical Systems, Inc. 2014-03-19 |
NITREX 86226045 not registered Dead/Abandoned |
Delta Medical Supply Group, Inc. 2014-03-19 |
 NITREX 78211793 2957976 Live/Registered |
COVIDIEN LP 2003-02-06 |
 NITREX 77857510 3847324 Live/Registered |
Eva-Glory Industrial Co., Ltd 2009-10-26 |
 NITREX 77590522 3962222 Dead/Cancelled |
Alliant Techsystems Inc. 2008-10-10 |
 NITREX 77482734 3590376 Dead/Cancelled |
American Agritech, LLC 2008-05-23 |
 NITREX 77141162 3664109 Dead/Cancelled |
Alliant Techsystems Inc. 2007-03-27 |
 NITREX 77141005 not registered Dead/Abandoned |
Alliant Techsystems Inc. 2007-03-27 |
 NITREX 77140999 not registered Dead/Abandoned |
Alliant Techsystems Inc. 2007-03-27 |
 NITREX 76508904 2824773 Live/Registered |
DELTA MEDICAL SYSTEMS, INC. 2003-04-23 |
NITREX 76508904 2824773 Live/Registered |
DELTA HOSPITAL SUPPLY, INC. 2003-04-23 |
NITREX 76508904 2824773 Live/Registered |
DELTA MEDICAL SUPPLY GROUP, INC. 2003-04-23 |
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