Babywire™

GUDID 20763000185835

GW BW1201 BABY WIRE V04

EV3, INC

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 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
Primary Device ID20763000185835
NIH Device Record Key4177d677-a682-4a03-81c4-58f07d33310f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBabywire™
Version Model NumberBW1201
Company DUNS117446916
Company NameEV3, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter
Guidewire Diameter0.31 Millimeter
Guidewire Length50 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000185831 [Primary]
GS120763000185835 [Package]
Contains: 00763000185831
Package: PK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, guide, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-16

On-Brand Devices [Babywire™]

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