Flo-Rester® Disposable Internal Vessel Occluder 60125BIOS

GUDID 50085412532054

Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a T configuration. Flo-Rester bulbs and tab are radiopaque.

SYNOVIS LIFE TECHNOLOGIES, INC.

Intravascular anastomosis occluder

• Primary Device ID: 50085412532054
• NIH Device Record Key: 8756bfeb-1e05-409f-8ef1-8f2020078303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flo-Rester® Disposable Internal Vessel Occluder
• Version Model Number: 60125
• Catalog Number: 60125BIOS
• 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
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412532059 [Primary]
GS1	50085412532054 [Package]; Contains: 00085412532059; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883696

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-Rester® Disposable Internal Vessel Occluder]

• 50085412532153: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532146: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532139: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532122: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532115: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532108: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532092: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532085: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532078: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532061: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532054: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532047: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532016: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532009: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531996: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531989: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531972: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531965: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531958: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531941: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531934: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531927: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531910: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531903: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o