GUDID 00643169014206

INTRDCR 673311 10PK 7F 11CM STDLNE DIALA

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00643169014206
• NIH Device Record Key: 6c9a3de2-1417-4e79-a6bc-c82aab361219
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 673311
• 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: 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

• Length: 11 Centimeter
• Length: 11 Centimeter
• Length: 11 Centimeter
• Length: 11 Centimeter
• Length: 11 Centimeter
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 7 French
• Length: 11 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169014206 [Primary]
GS1	20643169014200 [Package]; Package: PK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132617

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: 2016-08-25

Devices Manufactured by MEDTRONIC, INC.

• 00199150025381 - NA: 2025-06-27 CUSTOM PACK BB11P25R3 VCH CENT V A
• 20199150025521 - NA: 2025-06-27 CUSTOM PACK BB9G37R2 5PK L VD AC
• 00199150026326 - NA: 2025-06-27 CUSTOM PACK BB11Z33R8 ALINA CPB
• 00199150026579 - NA: 2025-06-27 CUSTOM PACK BB5722R48 CHRT INF
• 00199150026692 - NA: 2025-06-27 CUSTOM PACK BB8R73R14 NH ADULT PACK
• 00199150026715 - NA: 2025-06-27 CUSTOM PACK BB6M71R12 CP PRIME
• 00199150026746 - NA: 2025-06-27 CUSTOM PACK BB7A25R12 PED
• 00199150026753 - NA: 2025-06-27 CUSTOM PACK BB12E34R4 SUPPORT PACK