REVEAL® XT PATIENT ASSISTANT

GUDID 00643169472211

ACTV 9539 REVEAL US EN 3ED

MEDTRONIC, INC.

Implantable cardiac monitor

• Primary Device ID: 00643169472211
• NIH Device Record Key: 2b067579-9359-44a4-93d9-83869444f394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVEAL® XT PATIENT ASSISTANT
• Version Model Number: 9539
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169472211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103764

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2015-06-10

Devices Manufactured by MEDTRONIC, INC.

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• 20763000982946 - NA: 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD
• 00763000984007 - NA: 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG
• 00763000984021 - NA: 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE
• 00763000984151 - NA: 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
• 00763000984168 - NA: 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
• 00763000984175 - NA: 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK