TrailBlazer™

GUDID 00821684073964

PS SC-035-150 TRAILBLAZER V03

Covidien LP

Vascular guide-catheter, single-use

• Primary Device ID: 00821684073964
• NIH Device Record Key: 1d0d575f-dab7-42af-831e-83cfcade53b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrailBlazer™
• Version Model Number: SC-035-150
• Company DUNS: 968903703
• Company Name: Covidien LP
• Device Count: 5
• 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

Device Dimensions

• Outer Diameter: 0.89 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684073964 [Primary]
GS1	70843889022065 [Unit of Use]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-07
• Device Publish Date: 2019-05-30

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