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

• Primary Device ID: 00844735006148
• NIH Device Record Key: e0b02bc7-559f-4eff-b7ab-050ebdba3488
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM FLOW COUPLER MONITOR
• Version Model Number: GEM1020M-2
• Catalog Number: 515600000011
• 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)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)510-3318
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844735006148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191252

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: 2
• Public Version Date: 2020-02-05
• Device Publish Date: 2019-09-30

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