FlowMet™
GUDID 10860001276111
SENSOR FMET-IM-SENS-5
MEDTRONIC, INC.
Laser speckle blood flowmeter| Primary Device ID | 10860001276111 |
| NIH Device Record Key | 4f5b7a14-de7a-4aca-8927-520f29f57d10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlowMet™ |
| Version Model Number | FMET-IM-SENS-5 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Temperature transport 32°F to 122°F (0°C to 50°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity storage 50% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity transport 20% to 80% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude (storage and transport) -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 storage 73°F (23°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Temperature transport 32°F to 122°F (0°C to 50°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity storage 50% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity transport 20% to 80% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude (storage and transport) -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 storage 73°F (23°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Temperature transport 32°F to 122°F (0°C to 50°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity storage 50% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity transport 20% to 80% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude (storage and transport) -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 storage 73°F (23°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Temperature transport 32°F to 122°F (0°C to 50°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity storage 50% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity transport 20% to 80% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude (storage and transport) -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 storage 73°F (23°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Temperature transport 32°F to 122°F (0°C to 50°C) |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity storage 50% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Relative humidity transport 20% to 80% noncondensing |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude (storage and transport) -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 storage 73°F (23°C) |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860001276114 [Primary] |
| GS1 | 10860001276111 [Package] Contains: 00860001276114 Package: PK [5 Units] In Commercial Distribution |
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 |
Trademark Results [FlowMet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLOWMET 88342522 5889436 Live/Registered |
Laser Associated Sciences, Inc. 2019-03-15 |
 FLOWMET 79276566 not registered Live/Pending |
Ascenz Pte Ltd 2019-11-13 |
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