DETECT®

GUDID 20613994755623

MAPPING TOOL 10650 LES TST DETECT 5P 26L

MEDTRONIC, INC.

External pacemaker, epicardial pacing

• Primary Device ID: 20613994755623
• NIH Device Record Key: e5c0a0ea-dd20-4dd3-8e92-1fd854e3d9e6
• Commercial Distribution Discontinuation: 2016-08-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DETECT®
• Version Model Number: 10650
• 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

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994755629 [Primary]
GS1	20613994755623 [Package]; Contains: 00613994755629; Package: PK [5 Units]; Discontinued: 2016-08-09; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040812

FDA Product Code

• LDF: ELECTRODE, PACEMAKER, TEMPORARY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-05
• Device Publish Date: 2015-06-23

On-Brand Devices [DETECT®]

• 20613994755623: MAPPING TOOL 10650 LES TST DETECT 5P 26L
• 00613994377890: MAPPING TOOL 10650 LES TST DETECT 5P 18L