NITREX

GUDID 10821684009205

Guidewire

Covidien LP

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10821684009205
• NIH Device Record Key: 4f01ac7c-779a-45fe-9479-571d5bbc1906
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NITREX
• Version Model Number: N350801
• 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
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Length: 80 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	10821684009205 [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: 7
• Public Version Date: 2024-05-03
• 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