GUDID 20643169013968

INTRDCR 208211 10PK 8F 11CM INPT ST OB A

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20643169013968
• NIH Device Record Key: c4b8371d-cb37-4a1b-ac90-482ea083a2c7
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 208211
• 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
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter
• Catheter Gauge: 8 French
• Length: 11 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169013964 [Primary]
GS1	20643169013968 [Package]; Contains: 00643169013964; 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: 2017-02-02

Devices Manufactured by MEDTRONIC, INC.

• 20199150045680 - NA: 2025-09-22 CUSTOM PACK BB12R79R 10PK EVL COA 3/8 TU
• 00199150045693 - NA: 2025-09-22 CUSTOM PACK BB12R38R EVL 1/4ECC
• 00199150045808 - NA: 2025-09-22 CUSTOM PACK BB12F62R4 HLO UOF HE PA
• 00199150045815 - NA: 2025-09-22 CUSTOM PACK BB10B09R2 EVL EC SUP PK
• 00199150045822 - NA: 2025-09-22 CUSTOM PACK BB2S09R29 CV PACK
• 00199150045839 - NA: 2025-09-22 CUSTOM PACK BB12J21R6 EVL ADULT EC
• 00199150045860 - NA: 2025-09-22 CUSTOM PACK BB10B53R7 ADULT SUPPORT
• 00199150046010 - NA: 2025-09-22 CUSTOM PACK BB5G56R17 PUMP TBL