Sensia™

GUDID 00613994223807

IPG, SESR01, SENSIA, SR, IS-1, US

MEDTRONIC, INC.

Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive Single-chamber implantable pacemaker, rate-responsive

• Primary Device ID: 00613994223807
• NIH Device Record Key: 8e138c36-bb0e-4fe8-a1b3-41b7211465f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensia™
• Version Model Number: SESR01
• 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: true
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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 Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994223807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980035

FDA Product Code

• NVZ: Pulse generator, permanent, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-10
• Device Publish Date: 2014-09-23

On-Brand Devices [Sensia™]

• 00613994763327: IPG SESR01 SENSIA USA IS-1 SR NEW3 BCP
• 00613994763310: IPG SEDR01 SENSIA USA IS-1 DR NEW3 BCP
• 00613994223807: IPG, SESR01, SENSIA, SR, IS-1, US
• 00613994222138: IPG, SEDR01, SENSIA, DR, IS-1, US
• 00613994177957: IPG SEDR01 SENSIA IS-1 DR USA
• 00643169709065: IPG SESR01 SENSIA SR IS-1 US NS
• 00643169708945: IPG SESR01 SENSIA SR IS-1 US NS
• 00643169708891: IPG SEDR01 SENSIA DR IS-1 US NS