DEVICE: IVEA (00850003110103)

Device Identifier (DI) Information

IVEA
600S
In Commercial Distribution
16010
Firefly Medical, Inc.
00850003110103
GS1

1
194670134 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
42513 Transportable medical equipment stand, non-powered
A non-powered (non-active) transportable device [e.g., on wheels or easily movable] designed to support medical equipment (e.g., monitors, pumps, consoles) used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment.
Active false
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FDA Product Code

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Product Code Product Code Name
FOX Stand, Infusion
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e2c8fbeb-d211-4976-a879-51403edf01e7
December 11, 2024
2
November 09, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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