REVEAL® PATIENT ASSISTANT

GUDID 00643169472143

ACTV 9538 REVEAL US EN 3ED

MEDTRONIC, INC.

Implantable cardiac monitor

• Primary Device ID: 00643169472143
• NIH Device Record Key: 7d6b00cb-d71f-47ed-9d7c-d29b8378eb97
• Commercial Distribution Discontinuation: 2018-10-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: REVEAL® PATIENT ASSISTANT
• Version Model Number: 9538
• 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	00643169472143 [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: 6
• Public Version Date: 2020-01-09
• Device Publish Date: 2015-06-10

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• 00763000708917 - DiamondTemp™ FASTR RF Generator: 2024-12-23 GENERATOR CEDTG200 FASTR RF US
• 00763000709051 - DiamondTemp™ Irrigation Pump: 2024-12-23 IRRIGATION PUMP CEDTP100 US
• 00763000989156 - NA: 2024-12-23 CUSTOM PACK BB11C49R9 1/4 PACK
• 00763000989163 - NA: 2024-12-23 CUSTOM PACK BB12M25R1 TAPER BOOT