NITREX

GUDID 10821684001414

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 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: 10821684001414
• NIH Device Record Key: 609d7629-682e-470d-b6e3-7ead93e5ff25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NITREX
• Version Model Number: N180601
• 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
• 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: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.018 Inch
• Length: 60 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
• 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	10821684001414 [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: 4
• Public Version Date: 2024-02-09
• Device Publish Date: 2015-10-12

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• 10884521557048 - INVOS: 2024-04-22 Docking Station
• 10884521833869 - Endoflip: 2024-04-22 Refurbished 300 Pump System With Pre-Use Tube
• 20884521140216 - ClosureFast: 2024-04-15 Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m)
• 10884521543430 - LiquiBand Exceed: 2024-04-15 2-Octyl Cyanoacrylate
• 20884521140209 - ClosureFast: 2024-04-10 Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
• 10884521539921 - VenaSeal: 2024-04-09 VenaSeal Closure System