FlexCath Advance™

GUDID 00763000217136

SHEATH 4FC12 FLEXCATH ADVANCE 12F US

MEDTRONIC, INC.

Haemostasis valve

• Primary Device ID: 00763000217136
• NIH Device Record Key: 161fcf30-4749-4d35-a9b7-f98f50eee747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexCath Advance™
• Version Model Number: 4FC12
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000217136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183174

FDA Product Code

• DRA: CATHETER, STEERABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-03-02

On-Brand Devices [FlexCath Advance™]

• 00643169688872: SHEATH 4FC12 FLEXCATH ADVANCE 12F US
• 00763000043773: SHEATH 4FC12 FLEXCATH ADVANCE 12F US
• 00763000279905: SHEATH 990065 FLEXCATH SELECT 10 FR 65CM
• 00763000217136: SHEATH 4FC12 FLEXCATH ADVANCE 12F US
• 00763000418052: SHEATH 4FC12 FLEXCATH ADVANCE 12F US