AccessGUDID - DEVICE: GEM FLOW COUPLER (00844735006025)

GUDID

Device Identifier (DI) Information

Brand Name: GEM FLOW COUPLER
Version or Model: GEM2755 FC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 515101350010
Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC

Primary DI Number: 00844735006025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031284586 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DPW	FLOWMETER, BLOOD, CARDIOVASCULAR
MVR	Device,anastomotic,microvascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8b2e38bd-c722-4eef-b1ab-be0b0e878461
Public Version Date: July 20, 2023
Public Version Number: 4
DI Record Publish Date: October 08, 2015