GUDID 00643169782730

MONITOR 24965 USA MKT EIFU

MEDTRONIC, INC.

Cardiac pulse generator reader, professional

• Primary Device ID: 00643169782730
• NIH Device Record Key: e9f6dba5-2d14-4528-8981-bae4a2212399
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 24965
• 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

• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169782730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150614

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-04

Devices Manufactured by MEDTRONIC, INC.

• 20763000394091 - DxTerity™: 2025-01-28 DXT6JL45X DXT 6F 5PK 125CM JL45
• 20763000395180 - DxTerity™ TRA: 2025-01-28 CATH U5ULTRA35 DXT 5F 5PK 100CM UL35
• 00763000993924 - NA: 2025-01-28 CUSTOM PACK BB10Y59R12 FUSION
• 00763000993931 - NA: 2025-01-28 CUSTOM PACK BB7M46R26 SCV ADLT
• 00763000993948 - NA: 2025-01-28 CUSTOM PACK BB11U59R5 BYPASS TUBING
• 00763000993955 - NA: 2025-01-28 CUSTOM PACK BB8M65R3 RIDEOUT
• 08033477072012 - Pacific™ Plus: 2025-01-28 CATH PCP060300090 PLUS US D6L300UL900
• 08033477072029 - Pacific™ Plus: 2025-01-28 CATH PCP060300150 PLUS US D6L300UL1500