Flo-Thru Intraluminal Shunt® FT12125

GUDID 50085412532443

The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the ends of the bulbs allow blood to flow through the shunt and distal to the anastomosis.

SYNOVIS LIFE TECHNOLOGIES, INC.

Surgical intravascular shunt

• Primary Device ID: 50085412532443
• NIH Device Record Key: 1e58417f-8776-4ea3-a499-74fd094fa760
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flo-Thru Intraluminal Shunt®
• Version Model Number: FT-12125
• Catalog Number: FT12125
• Company DUNS: 017415781
• Company Name: SYNOVIS LIFE TECHNOLOGIES, 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: true
• 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)933-0303
• Email: Medinfo_medproducts@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412532448 [Primary]
GS1	50085412532443 [Package]; Contains: 00085412532448; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981624

FDA Product Code

• DXC: CLAMP, VASCULAR

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: 2016-09-24

On-Brand Devices [Flo-Thru Intraluminal Shunt®]

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• 50085412532504: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with
• 50085412532498: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with
• 50085412532481: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with
• 50085412532474: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with
• 50085412532467: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with
• 50085412532450: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with
• 50085412532443: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with
• 50085412532436: The sterile, single use Flo-Thru Intraluminal Shunt is a one-piece radiopaque silicone tube with