Capsure® EPI

GUDID 00681490116503

LEAD 4965-35 UNI EPI STEROID

MEDTRONIC, INC.

Epicardial pacing lead

• Primary Device ID: 00681490116503
• NIH Device Record Key: e8c3b41b-0160-49f6-a0f6-3c5998c704e5
• Commercial Distribution Discontinuation: 2018-05-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Capsure® EPI
• Version Model Number: 4965-35
• 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: true
• 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

Device Dimensions

• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490116503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950024

FDA Product Code

• NVN: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

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: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [Capsure® EPI]

• 00613994501813: LEAD 4965-50 US UNI EPI STEROID 50CM
• 00613994501776: LEAD 4965-35 US UNI EPI STERD 35CM
• 00613994501745: LEAD 4965-25 US UNI EPI STERD 25CM
• 00613994501721: LEAD 4965-15 US UNI EPI STEROID 15CM
• 00613994492340: LEAD 4968-60 US BIPOLAR EPICARDIAL 60CM
• 00613994492302: LEAD 4968-35 US BIPOLAR EPICARDIAL 35CM
• 00613994492272: LEAD 4968-25 US BIPOLAR EPICARDIAL 25CM
• 00681490116725: LEAD 4968-35 BIP EPI US
• 00681490116503: LEAD 4965-35 UNI EPI STEROID
• 00681490116336: LEAD 4965-15 CAPSURE EPI PACING US