GEM FLOW COUPLER MONITOR 515600000011

GUDID 00844735006148

The Flow COUPLER Monitor is a pulsed Doppler ultrasound system designed to detect vessel blood flow and confirm vessel patency intra and post-operatively at the anastomotic site as needed up to 7 days.

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit Vascular ultrasound system control unit
Primary Device ID00844735006148
NIH Device Record Keye0b02bc7-559f-4eff-b7ab-050ebdba3488
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM FLOW COUPLER MONITOR
Version Model NumberGEM1020M-2
Catalog Number515600000011
Company DUNS031284586
Company NameSYNOVIS MICRO COMPANIES ALLIANCE, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)510-3318
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844735006148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPWFLOWMETER, BLOOD, CARDIOVASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-05
Device Publish Date2019-09-30

On-Brand Devices [GEM FLOW COUPLER MONITOR]

00844735005127The FLOW COUPLER Monitor is a pulsed Doppler ultrasound system designed for the detection of blo
00844735006148The Flow COUPLER Monitor is a pulsed Doppler ultrasound system designed to detect vessel blood f

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