GUDID 20643169013982

INTRDCR 207223 10PK INPUT INTRDCR OBT

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20643169013982
• NIH Device Record Key: 518ffd62-3180-4ab1-9a53-5c7651d693e6
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 207223
• 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: 23 Centimeter
• Length: 23 Centimeter
• Length: 23 Centimeter
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter
• Catheter Gauge: 7 French
• Length: 23 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169013988 [Primary]
GS1	20643169013982 [Package]; Contains: 00643169013988; 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: 2017-02-03

Devices Manufactured by MEDTRONIC, INC.

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• 00763000747466 - NA: 2026-02-17 CATHETER C320LBBL48 LARGE CURVE 48 GBL
• 00763000747473 - NA: 2026-02-17 CATHETER C320LBBS45 SMALL CURVE 45 GBL
• 00763000747480 - NA: 2026-02-17 CATHETER C320LBBS48 SMALL CURVE 48 GBL
• 00199150006045 - N/A: 2026-02-10 COMM HANDSET KIT TH90D01 DBS EMANUAL US
• 00199150068302 - NA: 2026-02-10 CUSTOM PACK BB12M12R7 HLO CPB
• 20199150068351 - NA: 2026-02-10 CUSTOM PACK 12C75R1 20PK ACC BIDMC-PCK
• 20199150068382 - NA: 2026-02-10 CUSTOM PACK BB12C41R9 10PK ACC LNG PK