PACEART OPTIMA™ System

GUDID 00643169552296

SW POS12D15 MKT GLBL

MEDTRONIC, INC.

Patient health record information system application software

• Primary Device ID: 00643169552296
• NIH Device Record Key: 00d6411a-0c99-489e-8de5-7d2458d2b0c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACEART OPTIMA™ System
• Version Model Number: POS12D15
• 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 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169552296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110693

FDA Product Code

• DPS: ELECTROCARDIOGRAPH

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 OPTIMA™ System]

• 00643169956810: SW POS12D17 OPTIMA 1.7 GLOBAL
• 00643169956803: SW POS12D17 OPTIMA 1.7 GLOBAL
• 00643169707351: SW POS12D16 MKT GLBL
• 00643169552296: SW POS12D15 MKT GLBL
• 00643169463523: SW POS12D14 PACEART OPTIMA MKT GLBL
• 00643169411296: SW POS12D13 PACEART OPTIMA MKT GLBL
• 00643169345058: SW POS12D13 PACEART OPTIMA MKT GLBL
• 00763000083342: SW POS12D18 OPTIMA 1.8 GLOBAL