Gundry®

GUDID 20613994625568

CANNULA 94615 RCSP 15FR SIL MAN 4P 17L

MEDTRONIC, INC.

Coronary sinus cannula

• Primary Device ID: 20613994625568
• NIH Device Record Key: 44bbe2b6-7272-48fd-bf60-26766b6ade53
• Commercial Distribution Discontinuation: 2017-08-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Gundry®
• Version Model Number: 94615
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 4
• 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: false
• 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

Device Dimensions

• Catheter Gauge: 15 French
• Catheter Gauge: 15 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994625564 [Unit of Use]
GS1	20613994625568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860149

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-02

On-Brand Devices [Gundry®]

• 20643169454877: CANNULA 94113T RCSP 13F SIL-MAN 10PK 17L
• 20643169454723: CANNULA 94715 RCSP 15FR SIL-MAN 10PK 17L
• 20643169454716: CANNULA 94715 RCSP 15F SIL-MAN 10PK 17L
• 20643169454662: CANNULA 94615 RCSP 15FR SIL-MAN 4P 17L
• 20643169454655: CANNULA 94110 RCSP 10F SIL-MAN 4P 17L
• 20643169454525: CANNULA 94115T RCSP 15FR SIL-MAN 10P 17
• 20643169454389: CANNULA 94615 RCSP 15FR SIL-MAN 4PK 17L
• 20643169454334: CANNULA 94115 RCSP 15F SIL-MAN 4PK 17L
• 20643169454327: CANNULA 94115 RCSP 15FR SIL-MAN 4PK 17L
• 20643169454310: CANNULA 94113 RCSP 13FR SIL-MAN 4P 17L
• 20643169454303: CANNULA 94113 RCSP 13F SIL-MAN 4P 17L
• 20643169454297: CANNULA 94115T RCSP 15F SIL-MAN 10P 17L
• 20613994625919: CANNULA 94115 RCSP 15FR SIL-MAN 4PK 17L
• 20613994625896: CANNULA 94115T RCSP 15FR SIL-MAN 10P 17
• 20613994625742: CANNULA 94110 RCSP 10F SIL-MAN 4P 17L
• 20613994625728: CANNULA 94113 RCSP 13F SIL-MAN 4P 17L
• 20613994625711: CANNULA 94113 RCSP 13FR SIL-MAN 4P 17L
• 20613994625698: CANNULA 94113T RCSP 13F SIL-MAN 10PK 17L
• 20613994625568: CANNULA 94615 RCSP 15FR SIL MAN 4P 17L
• 20613994625506: CANNULA 94715 RCSP 15F SIL-MAN 10PK 17L