TrailBlazer™ Angled

GUDID 20763000104706

PS ASC-035-065 TRAILBLAZER ANGLED V03

Covidien LP

Vascular guide-catheter, single-use

Primary Device ID	20763000104706
NIH Device Record Key	31caf34f-213a-43e1-8b22-e75542021920
Commercial Distribution Status	In Commercial Distribution
Brand Name	TrailBlazer™ Angled
Version Model Number	ASC-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

Device Dimensions

Length	65 Centimeter
Length	65 Centimeter
Length	65 Centimeter
Length	65 Centimeter
Length	65 Centimeter
Length	65 Centimeter
Length	65 Centimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter
Device Size Text, specify	0
Catheter Gauge	4 French
Outer Diameter	1.04 Millimeter
Length	65 Centimeter

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 away from sunlight
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 away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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 *Store the catheter away from sunlight at room temperature in a dry place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
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	00763000104702 [Primary]
GS1	20763000104706 [Package] Contains: 00763000104702 Package: PK [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162384

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	3
Public Version Date	2019-01-23
Device Publish Date	2018-09-07

On-Brand Devices [TrailBlazer™ Angled]

20763000104737	PS ASC-035-150 TRAILBLAZER ANGLED V03
20763000104720	PS ASC-035-135 TRAILBLAZER ANGLED V03
20763000104713	PS ASC-035-090 TRAILBLAZER ANGLED V03
20763000104706	PS ASC-035-065 TRAILBLAZER ANGLED V03
20763000104690	PS ASC-018-150 TRAILBLAZER ANGLED V03
20763000104683	PS ASC-018-135 TRAILBLAZER ANGLED V03
20763000104676	PS ASC-018-090 TRAILBLAZER ANGLED V03
20763000104669	PS ASC-014-150 TRAILBLAZER ANGLED V03
20763000104652	PS ASC-014-135 TRAILBLAZER ANGLED V03
20763000104645	PS ASC-014-090 TRAILBLAZER ANGLED V03
20763000004891	PS ASC-035-150 TRAILBLAZER ANGLED V02
20763000004884	PS ASC-035-135 TRAILBLAZER ANGLED V02
20763000004877	PS ASC-035-090 TRAILBLAZER ANGLED V02
20763000004860	PS ASC-035-065 TRAILBLAZER ANGLED V02
20763000004853	PS ASC-018-150 TRAILBLAZER ANGLED V02
20763000004846	PS ASC-018-135 TRAILBLAZER ANGLED V02
20763000004839	PS ASC-018-090 TRAILBLAZER ANGLED V02
20763000004822	PS ASC-014-150 TRAILBLAZER ANGLED V02
20763000004815	PS ASC-014-135 TRAILBLAZER ANGLED V02
20763000004808	PS ASC-014-090 TRAILBLAZER ANGLED V02

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