Who else makes this device?

Name: GEM Flow Coupler
Brand: GEM Flow Coupler

Cardiovascular › MonitoringFlowmeter, Blood, Cardiovascular

GEM Flow Coupler

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…

Registry build 21.09.26

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.

4manufacturers in China registered for this device type

4catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code DPW
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Helen of Troy Macao Limited	Macau	Guangdong	Private-label distributor	11
Dongguan Mars Medical Products Co., Ltd.	Dongguan	Guangdong	Manufacturer	9
Onbo Electronic (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6

Record

Regulatory record for GEM Flow Coupler
Listed by	Synovis Micro Companies Alliance, United States
FDA product code	DPW
Device type	Flowmeter, Blood, Cardiovascular
Device class	Class 2
Regulation	21 CFR 870.2100
Record published	2015-10-08
Record revised	2023-07-20 (version 4)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for GEM Flow Coupler
Catalogue number	Size	Status
GEM2756 FC		In distribution
GEM2753 FC		In distribution
GEM2755 FC		In distribution
GEM2752 FC		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Transonic	Transonic Systems, Inc.	627
SonoTT Vascular Probe	Em-Tec GmbH	12
BiDop 7 probe	Koven Technology, Inc.	8
Medistim MiraQ Cardiac System	Medistim ASA	6
Medistim MiraQ Vascular System	Medistim ASA	6
FlowMet™	Medtronic, Inc.	4
CooperSurgical®	Coopersurgical, Inc.	4
Medistim System Activation Card	Medistim ASA	3
811-BL 24V Foreign & Domestic	Parks Medical Electronics, Inc.	3
Medistim MiraQ Ultimate System	Medistim ASA	3
Dopplex	Huntleigh Healthcare Ltd.	3
VascuChek Transceiver	Remington Medical, Inc.	2

Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K213974	2022-04-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.