FlowMet™

GUDID 00860001276121

SYSTEM FMET-IM-SYS

MEDTRONIC, INC.

Laser speckle blood flowmeter Laser speckle blood flowmeter Laser speckle blood flowmeter Laser speckle blood flowmeter Laser speckle blood flowmeter

• Primary Device ID: 00860001276121
• NIH Device Record Key: 08dd6745-f048-47e6-af00-34bfb152048a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowMet™
• Version Model Number: FMET-IM-SYS
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity 20% to 80% noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature 32°F to 122°F (0°C to 50°C)
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity 20% to 80% noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature 32°F to 122°F (0°C to 50°C)
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity 20% to 80% noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature 32°F to 122°F (0°C to 50°C)
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity 20% to 80% noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature 32°F to 122°F (0°C to 50°C)
• Special Storage Condition, Specify: Between 0 and 0 *Relative humidity 20% to 80% noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Altitude -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature 32°F to 122°F (0°C to 50°C)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001276121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192966

FDA Product Code

• DPW: FLOWMETER, BLOOD, CARDIOVASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-26
• Device Publish Date: 2021-07-16

On-Brand Devices [FlowMet™]

• 00860001276138: CABLE FMET-IM-RSC
• 00860001276121: SYSTEM FMET-IM-SYS
• 10860001276111: SENSOR FMET-IM-SENS-5
• 00763000502843: SYSTEM SERVICED FMET-IM-SYS-S