GUDID 10681490143766

ACCESSORY 6212S5 5PK NEW LEAD INTRODUCER

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10681490143766
• NIH Device Record Key: 37fee4ee-3866-4935-8382-c6d93201bed4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6212S5
• 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: true
• Device Combination Product: false
• Single Use: true
• 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
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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
• 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	00681490143769 [Primary]
GS1	10681490143766 [Package]; Contains: 00681490143769; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K965167

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2019-06-07
• Device Publish Date: 2017-01-03

Devices Manufactured by MEDTRONIC, INC.

• 00763000973506 - Sphere-9™ Catheter: 2025-01-21 CATHETER AFR-00001 SPHERE 9 US
• 00763000835392 - HawkOne™: 2025-01-06 ATHERECTOMY H1-14550 CUTTER DRIVER UNI
• 00763000989224 - NA: 2025-01-06 CUSTOM PACK BB12B64R6 GOLD H/L PACK
• 00763000990060 - NA: 2025-01-06 CUSTOM PACK BB12M44R UMCEP SHUNT PK
• 20763000990088 - NA: 2025-01-06 CUSTOM PACK 9D70R2 10PK HDR PK
• 20763000990460 - NA: 2025-01-06 CUSTOM PACK BB12M56R 10PK 1/4 SUPPLEMENT
• 20763000990484 - NA: 2025-01-06 CUSTOM PACK BB12M39R 2PK PACK C STRAIGH
• 20763000990507 - NA: 2025-01-06 CUSTOM PACK 11C82R1 4PK CARDIOPLEG