NITREX™
GUDID 20763000185385
GW N180603 NITREX V04
EV3, INC
Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual| Primary Device ID | 20763000185385 |
| NIH Device Record Key | 28e079cf-ce8a-43d9-9fd8-510c6db6b825 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NITREX™ |
| Version Model Number | N180603 |
| 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 | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Guidewire Length | 60 Centimeter |
| Device Size Text, specify | 0 |
| Guidewire Diameter | 0.46 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 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000185381 [Primary] |
| GS1 | 20763000185385 [Package] Contains: 00763000185381 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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