AqWire

GUDID 10821684005795

Hydrophilic Guidewire

Covidien LP

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10821684005795
• NIH Device Record Key: 5b7704a5-39d8-4e28-9873-b48401d69ebd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AqWire
• Version Model Number: A351801
• 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

• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Length: 180 Centimeter
• Outer Diameter: 0.035 Inch
• 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	10821684005795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000011

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: 2024-04-26
• Device Publish Date: 2015-10-23

On-Brand Devices [AqWire]

• 00821684058589: Hydrophilic Guidewire
• 00821684058572: Hydrophilic Guidewire
• 00821684058565: Hydrophilic Guidewire
• 00821684058558: Hydrophilic Guidewire
• 00821684058541: Hydrophilic Guidewire
• 00821684058534: Hydrophilic Guidewire
• 00821684058527: Hydrophilic Guidewire
• 00821684058510: Hydrophilic Guidewire
• 00821684058503: Hydrophilic Guidewire
• 00821684058497: Hydrophilic Guidewire
• 00821684058480: Hydrophilic Guidewire
• 00821684058473: Hydrophilic Guidewire
• 00821684058466: Hydrophilic Guidewire
• 00821684058459: Hydrophilic Guidewire
• 00821684058442: Hydrophilic Guidewire
• 00821684058435: Hydrophilic Guidewire
• 00821684058428: Hydrophilic Guidewire
• 00821684058411: Hydrophilic Guidewire
• 10821684005832: Hydrophilic Guidewire
• 10821684005801: Hydrophilic Guidewire
• 10821684007201: Hydrophilic Guidewire
• 10821684007195: Hydrophilic Guidewire
• 10821684007188: Hydrophilic Guidewire
• 10821684007171: Hydrophilic Guidewire
• 10821684007164: Hydrophilic Guidewire
• 10821684007157: Hydrophilic Guidewire
• 10821684005863: Hydrophilic Guidewire
• 10821684005856: Hydrophilic Guidewire
• 10821684005849: Hydrophilic Guidewire
• 10821684005825: Hydrophilic Guidewire
• 10821684005818: Hydrophilic Guidewire
• 10821684005795: Hydrophilic Guidewire
• 10821684005788: Hydrophilic Guidewire
• 10821684005771: Hydrophilic Guidewire
• 10821684005764: Hydrophilic Guidewire
• 10821684005757: Hydrophilic Guidewire