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

• Primary Device ID: 00844735005127
• NIH Device Record Key: bbe88caa-1990-4389-8312-bb727116e938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM FLOW COUPLER Monitor
• Version Model Number: GEM1020M
• Catalog Number: 515400000010
• Company DUNS: 031284586
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844735005127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093310

FDA Product Code

• DPW: FLOWMETER, BLOOD, CARDIOVASCULAR

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [GEM FLOW COUPLER Monitor]

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