PACEART® SYSTEM GET CONNECTED III

GUDID 00643169357730

SW PASDEVU3 DEV UPDATE MKT GLBL

MEDTRONIC, INC.

Patient health record information system application software

• Primary Device ID: 00643169357730
• NIH Device Record Key: 098b0758-2f27-4f71-9250-2e5cb3af93a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACEART® SYSTEM GET CONNECTED III
• Version Model Number: PASDEVU3
• 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: 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 Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169357730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024278

FDA Product Code

• KRE: ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT

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: 2016-04-01

On-Brand Devices [PACEART® SYSTEM GET CONNECTED III]

• 00613994845801: SW PASDEVUGCIII PACEART GLBL MR V 2.0
• 00613994533364: SW PASCLGCIII PACEART GLBL MR GCIII
• 00613994533333: SW PASDEMOGCIII PACEART GLBL MR GCIII
• 00613994533319: SW PASDOCGCIII PACEART GLBL MR GCIII
• 00613994533302: SW PASEXPGCIII PACEART GLBL MR GCIII
• 00613994533296: SW PASGATEGCIII PACEART GLBL MR GCIII
• 00613994533272: SW PASSATGCIII PACEART GLBL MR GCIII
• 00613994533265: SW PASTCGCIII PACEART GLBL MR GCIII
• 00613994533241: SW PASTMGCIII PACEART GLBL MR GCIII
• 00643169357730: SW PASDEVU3 DEV UPDATE MKT GLBL