GUDID 00613994897947

KIT 5866-9M ADAPTER FORMSCAPE NO CE

MEDTRONIC, INC.

Pacing/defibrillation lead electrical extension adaptor

• Primary Device ID: 00613994897947
• NIH Device Record Key: 46cba822-dc0f-4970-a213-2f087a4868a8
• Commercial Distribution Discontinuation: 2018-06-21
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 5866-9M
• 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 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994897947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911827

FDA Product Code

• DTD: pacemaker lead Adaptor

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: 2015-06-10

Devices Manufactured by MEDTRONIC, INC.

• 20199150003734 - NA: 2025-05-06 CUSTOM PACK BB10C88R1 5PK PRIME KIT
• 00199150008698 - NA: 2025-05-06 CUSTOM PACK BB11A81R6 RWJ PEDIMAG
• 20199150009200 - NA: 2025-05-06 CUSTOM PACK BB4G73R2 25PK PRT ACCSP
• 00199150009213 - NA: 2025-05-06 CUSTOM PACK BB11L40R5 UCD SM ADLT
• 00199150009251 - NA: 2025-05-06 CUSTOM PACK BB4Z56R7 CSP L SUP
• 00199150009268 - NA: 2025-05-06 CUSTOM PACK BB12P00R3 SUTTER MCS
• 00199150009336 - NA: 2025-05-06 CUSTOM PACK BB9R32R9 PED
• 00199150009343 - NA: 2025-05-06 CUSTOM PACK BB10P01R6 PRIME PED