NITREX™
GUDID 00821684058329
GW N351804 NITREX V03
Covidien LP
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 | 00821684058329 |
| NIH Device Record Key | c1ca20dd-e7d2-4517-8891-58c31038c5e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NITREX™ |
| Version Model Number | N351804 |
| Company DUNS | 968903703 |
| Company Name | Covidien LP |
| 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Outer Diameter | 0.89 Millimeter |
| Outer Diameter | 0.89 Millimeter |
| Outer Diameter | 0.89 Millimeter |
| Outer Diameter | 0.89 Millimeter |
| Outer Diameter | 0.89 Millimeter |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 180 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684058329 [Primary] |
| GS1 | 00821684065471 [Package] 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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-16 |
On-Brand Devices [NITREX™]
| 00821684058404 | GW N354002 NITREX V03 |
| 00821684058398 | GW N354001 NITREX V03 |
| 00821684058381 | GW N353001 NITREX V03 |
| 00821684058374 | GW N352604 NITREX V03 |
| 00821684058367 | GW N352603 NITREX V03 |
| 00821684058350 | GW N352602 NITREX V03 |
| 00821684058343 | GW N352601 NITREX V03 |
| 00821684058336 | GW N351805 NITREX V03 |
| 00821684058329 | GW N351804 NITREX V03 |
| 00821684058312 | GW N351803 NITREX V03 |
| 00821684058305 | GW N351455 NITREX V03 |
| 00821684058299 | GW N351454 NITREX V03 |
| 00821684058282 | GW N351453 NITREX V03 |
| 00821684058275 | GW N351452 NITREX V03 |
| 00821684058268 | GW N351451 NITREX V03 |
| 00821684058251 | GW N350801 NITREX V03 |
| 00821684058244 | GW N252601 NITREX V03 |
| 00821684058237 | GW N251802 NITREX V03 |
| 00821684058220 | GW N251801 NITREX V03 |
| 00821684058213 | GW N183002 NITREX V03 |
| 00821684058206 | GW N183001 NITREX V03 |
| 00821684058190 | GW N181806 NITREX V03 |
| 00821684058183 | GW N181805 NITREX V03 |
| 00821684058176 | GW N181804 NITREX V03 |
| 00821684058169 | GW N180802 NITREX V03 |
| 00821684058152 | GW N180801 NITREX V03 |
| 00821684058145 | GW N180603 NITREX V03 |
| 00821684058138 | GW N180601 NITREX V03 |
| 00821684058121 | GW N143001 NITREX V03 |
| 00821684058114 | GW N141802 NITREX V03 |
| 00821684058107 | GW N140801 NITREX V03 |
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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