IVEA
Basic Information
- Brand Name
- IVEA
- Primary DI
- 00850003110103
- Version / Model
- 600S
- Catalog Number
- 16010
- Company Name
- Firefly Medical, Inc.
- Labeler DUNS
- 194670134
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-09
- Public Version
- 1
- Public Version Date
- 2023-11-17
- Public Version Status
- New
- Public Device Record Key
- e2c8fbeb-d211-4976-a879-51403edf01e7
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FOX | Stand, Infusion | General Hospital | 880.6990 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850003110103 | GS1 |