GEM FLOW COUPLER

Basic Information

• Brand Name: GEM FLOW COUPLER
• Primary DI: 00844735006025
• Version / Model: GEM2755 FC
• Catalog Number: 515101350010
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC
• Labeler DUNS: 031284586
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-08
• Public Version: 4
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: 8b2e38bd-c722-4eef-b1ab-be0b0e878461

Device Description

The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe) attached to one of the FlowCOUPLER rings, and an external lead. The FlowCOUPLER rings are made of high density polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and probe which allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPW	FLOWMETER, BLOOD, CARDIOVASCULAR	Cardiovascular	870.2100	2
MVR	Device,anastomotic,microvascular	General, Plastic Surgery	878.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61382	Vascular anastomosis coupler, Doppler	An implantable device intended to be used to permanently join vascular structures (blood vessels) that includes an attached ultrasound (Doppler) probe for measuring blood flow through the anastomosis; it is typically used during microvascular surgery. It consists of two ring-shaped components over which the ends of the vessels are everted and held in place by pins; the rings are approximated using a dedicated device to create the anastomosis. The probe is connected to an external monitor and used to confirm vessel patency during and after the procedure for up to 14 days before it is removed.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844735006025	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]