NITREX
GUDID 10821684009212
Guidewire
Covidien LP
Cardiac/peripheral vascular guidewire, single-use| Primary Device ID | 10821684009212 |
| NIH Device Record Key | 0695a940-92a1-4ee8-b4d2-e85ff1c9f608 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NITREX |
| Version Model Number | N351454 |
| 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 | 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
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 0.035 Inch |
| Length | 145 Centimeter |
| Device Size Text, specify | 0 |
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 *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 | 10821684009212 [Primary] |
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 | 5 |
| Public Version Date | 2024-04-29 |
| Device Publish Date | 2015-10-23 |
On-Brand Devices [NITREX]
| 10821684001414 | Guidewire |
| 10821684009281 | Guidewire |
| 10821684009274 | Guidewire |
| 10821684009267 | Guidewire |
| 10821684009250 | Guidewire |
| 10821684009243 | Guidewire |
| 10821684009236 | Guidewire |
| 10821684009229 | Guidewire |
| 10821684009212 | Guidewire |
| 10821684009205 | Guidewire |
| 10821684009199 | Guidewire |
| 10821684009182 | Guidewire |
| 10821684009175 | Guidewire |
| 10821684009151 | Guidewire |
| 10821684009144 | Guidewire |
| 10821684009137 | Guidewire |
| 10821684009120 | Guidewire |
| 10821684009113 | Guidewire |
| 10821684009106 | Guidewire |
| 10821684009090 | Guidewire |
| 10821684009083 | Guidewire |
| 10821684009076 | Guidewire |
| 10821684009069 | Guidewire |
| 10821684009052 | Guidewire |
| 10821684009045 | Guidewire |
| 10821684009038 | Guidewire |
| 10821684009021 | Guidewire |
| 10821684009014 | Guidewire |
| 10821684009007 | Guidewire |
| 10821684001438 | Guidewire |
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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