TrailBlazer™

GUDID 20763000770369

PS ASC-035-090 TRAILBLAZER ANGLED V04

MEDTRONIC, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 20763000770369
• NIH Device Record Key: 880a6ec2-f370-460d-a7df-63dde98db31b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrailBlazer™
• Version Model Number: ASC-035-090
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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

Device Dimensions

• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 90 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. 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 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000770365 [Primary]
GS1	20763000770369 [Package]; Contains: 00763000770365; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08

On-Brand Devices [TrailBlazer™]

• 20763000762821: PS SC-035-150 TRAILBLAZER V06
• 20763000762814: PS SC-035-135 TRAILBLAZER V06
• 20763000762807: PS SC-035-090 TRAILBLAZER V06
• 20763000762791: PS SC-035-065 TRAILBLAZER V06
• 20763000762784: PS SC-018-150 TRAILBLAZER V06
• 20763000762777: PS SC-018-135 TRAILBLAZER V06
• 20763000762760: PS SC-018-090 TRAILBLAZER V06
• 20763000762753: PS SC-014-150 TRAILBLAZER V06
• 20763000762746: PS SC-014-135 TRAILBLAZER V06
• 20763000770383: PS ASC-035-150 TRAILBLAZER ANGLED V04
• 20763000770376: PS ASC-035-135 TRAILBLAZER ANGLED V04
• 20763000770369: PS ASC-035-090 TRAILBLAZER ANGLED V04
• 20763000770352: PS ASC-035-065 TRAILBLAZER ANGLED V04
• 20763000770345: PS ASC-018-150 TRAILBLAZER ANGLED V04
• 20763000770338: PS ASC-018-135 TRAILBLAZER ANGLED V04
• 20763000770321: PS ASC-018-090 TRAILBLAZER ANGLED V04
• 20763000770314: PS ASC-014-150 TRAILBLAZER ANGLED V04
• 20763000770307: PS ASC-014-135 TRAILBLAZER ANGLED V04
• 20763000770291: PS ASC-014-090 TRAILBLAZER ANGLED V04