FlowMet-R

GUDID 00860001276107

LASER ASSOCIATED SCIENCES, INC.

Laser Doppler blood flowmeter

• Primary Device ID: 00860001276107
• NIH Device Record Key: 81ec0f90-607c-424e-9565-854ae52863f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowMet-R
• Version Model Number: FlowMet-R
• Company DUNS: 078853361
• Company Name: LASER ASSOCIATED SCIENCES, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001276107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182494

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: 2019-04-08
• Device Publish Date: 2019-03-29