FlexCath Cross™ Transseptal Solution

GUDID 00763000925161

NDL 900309 FLEXCATH CROSS SL 81CM EIFU

MEDTRONIC, INC.

Cardiac transseptal access electrosurgical dilator/needle

• Primary Device ID: 00763000925161
• NIH Device Record Key: 5722740c-e982-4adb-85db-2073db86c795
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexCath Cross™ Transseptal Solution
• Version Model Number: 900309
• 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

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000925161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220047

FDA Product Code

• DYB: Introducer, catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-18
• Device Publish Date: 2025-08-10

On-Brand Devices [FlexCath Cross™ Transseptal Solution]

• 00763000925178: NDL 900310 FLEXCATH CROSS FCC 10FR EIFU
• 00763000925154: NDL 900308 FLEXCATH CROSS WT 75CM EIFU
• 00763000925109: NDL 900303 FLEXCATH CROSS VZ 71CM EIFU
• 00763000925093: NDL 900302 FLEXCATH CROSS SL 63CM EIFU
• 00763000925185: NDL 900311 FLEXCATH CROSS FCC 12FR EIFU
• 00763000925161: NDL 900309 FLEXCATH CROSS SL 81CM EIFU
• 00763000925147: NDL 900307 FLEXCATH CROSS MH 81CM EIFU
• 00763000925130: NDL 900306 FLEXCATH CROSS MH 63CM EIFU
• 00763000925116: NDL 900304 FLEXCATH CROSS FC 65CM EIFU
• 00763000925086: NDL 900301 FLEXCATH CROSS AG 71CM EIFU
• 00763000925079: NDL 900300 FLEXCATH CROSS AG 61CM EIFU