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

Devices Manufactured by MEDTRONIC, INC.

• 00199150042005 - NA: 2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8
• 00199150042012 - NA: 2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM
• 00199150042029 - NA: 2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4
• 00199150042043 - NA: 2025-08-29 CUSTOM PACK BB9E98R16 EVL WCH PED
• 00199150042067 - NA: 2025-08-29 CUSTOM PACK BB7E31R31 EVL 1 EVT 1/4
• 00199150042739 - NA: 2025-08-29 CUSTOM PACK BB7V67R13 HLO PRESBY
• 00199150042746 - NA: 2025-08-29 CUSTOM PACK BB0C00R32 EVL 3/8SUPPT
• 00763000658960 - Profile 3D™: 2025-08-29 HANDLE 7686L ANNULOPLASTY2 MDR