Babywire

GUDID 10821684007041

Double Ended Nitinol 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

• Primary Device ID: 10821684007041
• NIH Device Record Key: 2752c972-082d-4ddc-8a23-f3bf82bdf635
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Babywire
• Version Model Number: BW1201
• 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

Device Dimensions

• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.012 Inch
• Length: 50 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10821684007041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895899

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: 2024-05-20
• Device Publish Date: 2015-10-09

On-Brand Devices [Babywire]

• 10821684007041: Double Ended Nitinol Guidewire
• 10821684007034: Double Ended Nitinol Guidewire