Paceart Optima™ System 1.6 with Analytics

GUDID 00643169876927

SW POS12D16A OPTIMA 1.6 WITH ANALYTICS

MEDTRONIC, INC.

Patient health record information system application software

• Primary Device ID: 00643169876927
• NIH Device Record Key: ecd8a224-dde1-4f74-aafc-c95c36c9eaaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paceart Optima™ System 1.6 with Analytics
• Version Model Number: POS12D16A
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169876927 [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: 2017-01-16

Devices Manufactured by MEDTRONIC, INC.

• 00199150050161 - NA: 2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK
• 00199150050178 - NA: 2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E
• 00199150050185 - NA: 2025-09-29 CUSTOM PACK BB4Q12R27 UNIV H/L
• 20199150050202 - NA: 2025-09-29 CUSTOM PACK BB12P63R 4PK GPS TABLE PK
• 00199150050871 - NA: 2025-09-29 CUSTOM PACK BB11R66R2 TBL 1/4
• 00763000877033 - SPRINTER® LEGEND: 2025-09-29 BALLOON SPL15006X SPR LEG RX US M
• 00763000877040 - SPRINTER® LEGEND: 2025-09-29 BALLOON SPL15010X SPR LEG RX US M
• 00763000877057 - SPRINTER® LEGEND: 2025-09-29 BALLOON SPL15012X SPR LEG RX US M