GEM FLOW COUPLER Monitor 515400000010

GUDID 00844735005127

The FLOW COUPLER Monitor is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels.

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
Primary Device ID00844735005127
NIH Device Record Keybbe88caa-1990-4389-8312-bb727116e938
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM FLOW COUPLER Monitor
Version Model NumberGEM1020M
Catalog Number515400000010
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)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844735005127 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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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