Babywire™

GUDID 20763000185835

GW BW1201 BABY WIRE V04

EV3, INC

Peripheral vascular guidewire, manual

• Primary Device ID: 20763000185835
• NIH Device Record Key: 4177d677-a682-4a03-81c4-58f07d33310f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Babywire™
• Version Model Number: BW1201
• Company DUNS: 117446916
• Company Name: EV3, INC
• 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(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

Device Dimensions

• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter
• Guidewire Diameter: 0.31 Millimeter
• Guidewire Length: 50 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the guidewire away from sunlight at room temperature in a dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000185831 [Primary]
GS1	20763000185835 [Package]; Contains: 00763000185831; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-24
• Device Publish Date: 2020-08-16

On-Brand Devices [Babywire™]

• 20763000185835: GW BW1201 BABY WIRE V04
• 20763000185828: GW BW1200 BABY WIRE V04