Babywire™

GUDID 00821684058084

GW BW1200 BABY WIRE V03

Covidien LP

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual 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 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: 00821684058084
• NIH Device Record Key: 26e4b45c-d795-419c-abc2-0a715c0148ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Babywire™
• Version Model Number: BW1200
• 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.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
• 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: 0.31 Millimeter
• Outer Diameter: 0.31 Millimeter
• Outer Diameter: 0.31 Millimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.31 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 Inch
• Device Size Text, specify: 0
• Length: 18 Centimeter
• Outer Diameter: 0.012 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 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight
• 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
• 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	00821684058084 [Primary]
GS1	00821684065235 [Package]; Package: PK [10 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-16

On-Brand Devices [Babywire™]

• 00821684058091: GW BW1201 BABY WIRE V03
• 00821684058084: GW BW1200 BABY WIRE V03