FLUOBEAM LX Red

GUDID B475FBLXR0

Fluorescence imaging system

FLUOPTICS

Intraoperative parathyroid detection system control unit

• Primary Device ID: B475FBLXR0
• NIH Device Record Key: 37d06009-3f43-42e9-b9a1-385eb99fedc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLUOBEAM LX Red
• Version Model Number: FBLXR
• Company DUNS: 260631677
• Company Name: FLUOPTICS
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B475FBLXR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233564

FDA Product Code

• QDG: Parathyroid Autofluorescence Imaging Device

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: 2024-05-14
• Device Publish Date: 2024-05-06

Devices Manufactured by FLUOPTICS

• B475FBLXR0 - FLUOBEAM LX Red: 2024-05-14Fluorescence imaging system
• B475FBLXR0 - FLUOBEAM LX Red: 2024-05-14 Fluorescence imaging system
• B475FMSA0 - FLUOPOD: 2023-10-09
• B475FKCL0 - FLUOCART: 2022-02-08
• B475FBLM0 - FLUOBEAM LM: 2021-02-26 Fluorescence imaging system
• B475LXHO0 - FLUOCLIP: 2021-02-26
• B475FBLX0 - FLUOBEAM LX: 2019-09-13 Fluorescence imaging system
• B475FB800CLV190 - FLUOBEAM 800: 2018-07-26
• B475FC800CLV190 - FLUOCASE 800: 2018-07-26