IVEA 16010

GUDID 00850003110103

IVEA is an innovative, 4-wheeled mobile patient equipment management device to aid the in-hospital ambulation process by organizing and mobilizing patient equipment when the patient is ready to ambulate. IVEA, designed by nurses to improve mobility, safety, efficiency, and storability, can replace the traditional IV pole and be set up at a patient’s bedside ready to move when the patient is ready. As a mobile equipment management tool, IVEA organizes and secures supportive equipment such as IVs, infusion pumps, oxygen tank, chest tubes, urinary catheters, drainage devices, PCAs, and feeding tubes, and eliminates the need to transfer equipment from one device to another for patient ambulation. IVEA can be set up before the patient arrives to reduce prep time at arrival and remain set up for every time the patient ambulates. IVEA makes it possible for fewer clinical staff to safely ambulate a patient. When not in use, IVEA folds and stores easily to reduce clutter.

Firefly Medical, Inc.

Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered

• Primary Device ID: 00850003110103
• NIH Device Record Key: e2c8fbeb-d211-4976-a879-51403edf01e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVEA
• Version Model Number: 600S
• Catalog Number: 16010
• Company DUNS: 194670134
• Company Name: Firefly Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00850003110103 [Primary]

FDA Product Code

• FOX: Stand, Infusion

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: 2023-11-17
• Device Publish Date: 2023-11-09

Devices Manufactured by Firefly Medical, Inc.

• 00850003110103 - IVEA: 2023-11-17IVEA is an innovative, 4-wheeled mobile patient equipment management device to aid the in-hospital ambulation process by organizing and mobilizing patient equipment when the patient is ready to ambulate. IVEA, designed by nurses to improve mobility, safety, efficiency, and storability, can replace the traditional IV pole and be set up at a patient’s bedside ready to move when the patient is ready. As a mobile equipment management tool, IVEA organizes and secures supportive equipment such as IVs, infusion pumps, oxygen tank, chest tubes, urinary catheters, drainage devices, PCAs, and feeding tubes, and eliminates the need to transfer equipment from one device to another for patient ambulation. IVEA can be set up before the patient arrives to reduce prep time at arrival and remain set up for every time the patient ambulates. IVEA makes it possible for fewer clinical staff to safely ambulate a patient. When not in use, IVEA folds and stores easily to reduce clutter.
• 00850003110103 - IVEA: 2023-11-17 IVEA is an innovative, 4-wheeled mobile patient equipment management device to aid the in-hospital ambulation process by organiz
• 00850003110110 - Oxygen (O2) Tank Booster Accessory for IVEA: 2023-09-15 An accessory that attaches to IVEA to allow compatibility and placement of shorter (D size) oxygen tanks on the device