Flo-X FX10

GUDID 00815128020652

The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally invasive surgery while maintaining visualization of the surgical site.

MINIMALLY INVASIVE DEVICES, INC.

Endoscopic antifog solution

• Primary Device ID: 00815128020652
• NIH Device Record Key: 7b9c98bf-2670-4608-9072-4b84f67be2bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flo-X
• Version Model Number: FX10
• Catalog Number: FX10
• Company DUNS: 793517660
• Company Name: MINIMALLY INVASIVE DEVICES, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-614-340-3349
• Email: inquiries@floshield.com
• Phone: 1-614-340-3349
• Email: inquiries@floshield.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 89 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815128020652 [Primary]
GS1	10815128020659 [Package]; Package: Sales Box [6 Units]; In Commercial Distribution

FDA Product Code

• OCT: Anti Fog Solution And Accessories, Endoscopy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-25

Devices Manufactured by MINIMALLY INVASIVE DEVICES, INC.

• 00815128020003 - FloShield/Air: 2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
• 10815128020017 - FloShield/Air: 2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
• 10815128020024 - FloShield/Air: 2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
• 00815128020034 - FloShield/Air: 2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
• 10815128020048 - FloShield/Air: 2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
• 00815128020058 - FloShield/Air: 2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
• 00815128020065 - FloShield/Air: 2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d
• 00815128020072 - FloShield/Air: 2019-04-09 The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative d