Babywire™

GUDID 00821684058091

GW BW1201 BABY WIRE V03

Covidien LP

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Primary Device ID	00821684058091
NIH Device Record Key	f61ee933-d53f-4247-8379-da07c8419771
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	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

Device Dimensions

Outer Diameter	0.31 Millimeter
Outer Diameter	0.31 Millimeter
Outer Diameter	0.31 Millimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter
Length	50 Centimeter
Outer Diameter	0.31 Millimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684058091 [Primary]
GS1	00821684065242 [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