GUDID 00643169023239

KIT 20MRK ARCTIC FRONT MANUALRETRACTION

MEDTRONIC, INC.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00643169023239
• NIH Device Record Key: 919cfcaf-b378-4268-95be-37ca159d6a0f
• Commercial Distribution Discontinuation: 2018-11-09
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 20MRK
• 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: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 136 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169023239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100010

FDA Product Code

• OAE: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

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: 2020-05-06
• Device Publish Date: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

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• 20763000770338 - TrailBlazer™: 2024-07-16 PS ASC-018-135 TRAILBLAZER ANGLED V04
• 20763000770345 - TrailBlazer™: 2024-07-16 PS ASC-018-150 TRAILBLAZER ANGLED V04
• 20763000770352 - TrailBlazer™: 2024-07-16 PS ASC-035-065 TRAILBLAZER ANGLED V04
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