NITREX™
GUDID 00821684058404
GW N354002 NITREX V03
Covidien LP
Peripheral vascular guidewire, manual| Primary Device ID | 00821684058404 |
| NIH Device Record Key | dd17ef83-6a66-4767-a5f2-19c44370c08b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NITREX™ |
| Version Model Number | N354002 |
| 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
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 | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.89 Millimeter |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 400 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684058404 [Primary] |
| GS1 | 00821684065556 [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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.