GUDID 20643169014187

INTRDCR 683311 10PK 8F 11CM STDLNE DIALA

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20643169014187
• NIH Device Record Key: 1467ea17-998a-40cb-96c6-eb90cd7875ab
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 683311
• 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

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169014183 [Primary]
GS1	20643169014187 [Package]; Contains: 00643169014183; Package: PK [10 Units]; Discontinued: 2018-10-05; Not 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: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-08-20

Devices Manufactured by MEDTRONIC, INC.

• 00199150037995 - NA: 2025-08-15 CUSTOM PACK BB12P51R4 EVL ORS PK
• 00199150038060 - NA: 2025-08-15 CUSTOM PACK BB12P06R CONE EXCHANGE
• 00199150038800 - NA: 2025-08-15 CUSTOM PACK BB12N98R 1/4 KIT
• 00199150038930 - NA: 2025-08-15 CUSTOM PACK BB12B01R2 PEDS CH ADAPT
• 00199150039043 - NA: 2025-08-15 CUSTOM PACK BB8M10R14 E SUPPORT
• 00199150039050 - NA: 2025-08-15 CUSTOM PACK BB6M86R4 INFT V
• 00199150039067 - NA: 2025-08-15 CUSTOM PACK BB11F63R2 PEDI ADAPTATI
• 00199150039210 - NA: 2025-08-15 CUSTOM PACK BB11U75R5 GOLD PACK