GUDID 20643169014040

INTRDCR 206211 10PK 6F 11CM INPT SHTH OB

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20643169014040
• NIH Device Record Key: 9799e2d3-afe0-4b12-a4e5-e602af46ea80
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 206211
• 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: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French
• Length: 11 Centimeter
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169014046 [Primary]
GS1	20643169014040 [Package]; Contains: 00643169014046; 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: 2017-02-02

Devices Manufactured by MEDTRONIC, INC.

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• 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