GUDID 00681490153553

ACCESS 6981M KIT EXTENDER UNI IS-1

MEDTRONIC, INC.

Pacing/defibrillation lead electrical extension adaptor

• Primary Device ID: 00681490153553
• NIH Device Record Key: a7f96946-f25f-47c9-a923-347b17d84671
• Commercial Distribution Discontinuation: 2018-05-02
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 6981M
• 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	00681490153553 [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: 3
• Public Version Date: 2018-07-11
• Device Publish Date: 2015-06-10

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