DEVICE: Continuous Ventilator (17290013641967)
Device Identifier (DI) Information
Continuous Ventilator
V200-0002-PKU
In Commercial Distribution
FLIGHT MEDICAL INNOVATIONS LTD
V200-0002-PKU
In Commercial Distribution
FLIGHT MEDICAL INNOVATIONS LTD
F60T DL ENG Int Mixer-UM
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? |
---|---|---|---|---|
34851 | Anaesthesia ventilator |
A mains electricity (AC-powered) stand-alone, automatic cycling device used to assist and control alveolar ventilation during general anaesthesia, and is compatible with inhaled anaesthetic agents. It has fewer functions and is less complex to operate than an intensive care ventilator, but adequately meets the patient's ventilation needs for oxygen (O2) and carbon dioxide (CO2) exchange to maintain normal blood gas concentrations. The device provides a mechanical means to deliver the breathing gas to the patient in a controlled pattern, and is equipped with alarms to warn of changes in respiration or the onset of unsafe operating conditions.
|
Active | false |
36289 | Transport electric ventilator |
An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CBK | Ventilator, Continuous, Facility Use |
NOU | Continuous, Ventilator, Home Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K143035 | 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
0d329c30-65d6-46f3-913d-326e2c1cc2fd
July 06, 2018
3
October 06, 2017
July 06, 2018
3
October 06, 2017
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