DEVICE: VOCSN 24 Volt Wheelchair Power Cable (00855573007440)
Device Identifier (DI) Information
VOCSN 24 Volt Wheelchair Power Cable
PRT-01027-000
In Commercial Distribution
PRT-01027-000
VENTEC LIFE SYSTEMS, INC.
PRT-01027-000
In Commercial Distribution
PRT-01027-000
VENTEC LIFE SYSTEMS, INC.
VOCSN 24 Volt Wheelchair Power Cable
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
47366 | Emergency airway clearance suction system, electric |
A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes an electrically-powered suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.
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Active | false |
36998 | In-exsufflator |
A portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications.
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Active | false |
31321 | Mobile/portable oxygen concentrator |
A mobile/portable mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is used in a home, institution, or a vehicle and typically has internal batteries for transportable use.
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Active | false |
47083 | Portable electric ventilator |
A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTA | Pump, Portable, Aspiration (Manual Or Powered) |
NHJ | Device, Positive Pressure Breathing, Intermittent |
CAW | Generator, Oxygen, Portable |
NOU | Continuous, Ventilator, Home Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K162877 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4d217f36-147b-4c14-911f-0c0f8c67f8f3
April 20, 2020
2
January 30, 2019
April 20, 2020
2
January 30, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined