GUDID 20643169014385

INTRDCR 040037A 10PK 17CM 5F DILATOR

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20643169014385
• NIH Device Record Key: 89b76e1b-b9a7-4e11-8e84-3b091667b9a9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 040037A
• 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: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French
• Length: 11 Centimeter
• Outer Diameter: 0.97 Millimeter
• Catheter Gauge: 5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169014381 [Primary]
GS1	20643169014385 [Package]; Contains: 00643169014381; Package: PK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955785

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.

• 00199150042098 - NA: 2025-09-08 CUSTOM PACK BB8B09R20 HLN OR INFANT
• 00199150042661 - NA: 2025-09-08 CUSTOM PACK BB0C01R32 EVL 1/4 SUPPT
• 00199150042753 - NA: 2025-09-08 CUSTOM PACK BB9F06R5 EVL WCH NEONA
• 00199150043392 - NA: 2025-09-08 CUSTOM PACK BB12D74R5 HLO ALLIDON
• 00199150043507 - NA: 2025-09-08 CUSTOM PACK BB12Q89R1 EVL 3/8
• 00199150043538 - NA: 2025-09-08 CUSTOM PACK BB12Q60R1 HLO ST BERNAR
• 00199150044436 - NA: 2025-09-08 CUSTOM PACK BB9R01R23 HLN OR PEDIA
• 20199150044454 - NA: 2025-09-08 CUSTOM PACK BB12R78R 5PK ACC PDEVL