SENSOR FMET
FlowMet™ - FMET-IM-SENS-5
Device Description
An electrically-powered device designed to use laser speckle imaging to measure micro- and macrovascular blood circulation and to assess the extent of vascular flow and associated changes [i.e., due to clots, stenosis, vascular tone changes, mechanical damage, and peripheral vascular disease (PVD)]. It uses laser light projected onto tissue and a multi-element light detector (e.g., a digital camera) to detect remitted light, thus enabling a measure of spatial variation (map) of blood flow. The device typically consists of one or more optical sensors connected to a software-controlled control/visual display unit.
Environmental Conditions
- Temperature transport 32°F to 122°F (0°C to 50°C)
- Keep dry
- Relative humidity storage 50% noncondensing
- Relative humidity transport 20% to 80% noncondensing
- Altitude (storage and transport) -1,000 ft to 9,482 ft (-304 m to 3,000 m); 66 kPa to 106 kPa
- Temperature storage 73°F (23°C)
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DPW
Device Name: Flowmeter, Blood, Cardiovascular
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.2100
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 10860001276111
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00860001276114
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PK
Device Id: 00860001276114
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A