TrailBlazer™

GUDID 00821684058022

PS SC-035-065 TRAILBLAZER V03

Covidien LP

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

Primary Device ID	00821684058022
NIH Device Record Key	813024c1-40bd-4766-baf7-e50590eb1a35
Commercial Distribution Status	In Commercial Distribution
Brand Name	TrailBlazer™
Version Model Number	SC-035-065
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(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
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Outer Diameter	0.89 Millimeter
Outer Diameter	0.89 Millimeter
Outer Diameter	0.89 Millimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter
Length	65 Centimeter
Outer Diameter	0.89 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684058022 [Primary]
GS1	00821684073933 [Package] Package: PK [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092299

FDA Product Code

DQY	CATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2019-11-11
Device Publish Date	2016-04-04

On-Brand Devices [TrailBlazer™]

20643169996179	PS SC-035-150 TRAILBLAZER V04
20643169996162	PS SC-035-135 TRAILBLAZER V04
20643169996155	PS SC-035-090 TRAILBLAZER V04
20643169996148	PS SC-035-065 TRAILBLAZER V04
20643169996131	PS SC-018-150 TRAILBLAZER V04
20643169996124	PS SC-018-135 TRAILBLAZER V04
20643169996117	PS SC-018-090 TRAILBLAZER V04
20643169996100	PS SC-014-150 TRAILBLAZER V04
20643169996094	PS SC-014-135 TRAILBLAZER V04
00821684058077	PS SC-035-150 TRAILBLAZER V03
00821684058046	PS SC-035-135 TRAILBLAZER V03
00821684058039	PS SC-035-090 TRAILBLAZER V03
00821684058022	PS SC-035-065 TRAILBLAZER V03
00821684058015	PS SC-018-150 TRAILBLAZER V03
00821684058008	PS SC-018-135 TRAILBLAZER V03
00821684057995	PS SC-018-090 TRAILBLAZER V03
00821684057988	PS SC-014-150 TRAILBLAZER V03
00821684057971	PS SC-014-135 TRAILBLAZER V03
00821684073964	PS SC-035-150 TRAILBLAZER V03
20763000104829	PS SC-035-150 TRAILBLAZER V05
20763000104812	PS SC-035-135 TRAILBLAZER V05
20763000104805	PS SC-035-090 TRAILBLAZER V05
20763000104799	PS SC-035-065 TRAILBLAZER V05
20763000104782	PS SC-018-150 TRAILBLAZER V05
20763000104775	PS SC-018-135 TRAILBLAZER V05
20763000104768	PS SC-018-090 TRAILBLAZER V05
20763000104751	PS SC-014-150 TRAILBLAZER V05
20763000104744	PS SC-014-135 TRAILBLAZER V05

Trademark Results [TrailBlazer]

Mark Image Registration \| Serial	Company Trademark Application Date
TRAILBLAZER 98469001 not registered Live/Pending	GROW COACHING SOLUTIONS, LLC 2024-03-26
TRAILBLAZER 98456859 not registered Live/Pending	Aurora Cooperative Elevator Company 2024-03-19
TRAILBLAZER 98385011 not registered Live/Pending	Generations of Sonoma, LLC 2024-01-31
TRAILBLAZER 98351133 not registered Live/Pending	Tarrant County College District 2024-01-10
TRAILBLAZER 98303111 not registered Live/Pending	TP-Holiday Group Limited 2023-12-07
TRAILBLAZER 98299673 not registered Live/Pending	Trailblazer Women's Wellness, PLLC 2023-12-05
TRAILBLAZER 98180580 not registered Live/Pending	Spinal Elements, Inc. 2023-09-14
TRAILBLAZER 97722935 not registered Live/Pending	Athletic Brewing Company LLC 2022-12-19
TRAILBLAZER 97670112 not registered Live/Pending	Trailblazer Energy Resources, LLC 2022-11-09
TRAILBLAZER 90787630 not registered Live/Pending	Made In Nature, LLC 2021-06-22
TRAILBLAZER 90274398 not registered Live/Pending	Intabio, Inc. 2020-10-23
TRAILBLAZER 88828665 not registered Live/Pending	eSite Analytics, Inc. 2020-03-10