DEVICE: VENT (00847946094515)
Device Identifier (DI) Information
VENT
800-EMVP-04-SNS
In Commercial Distribution
Zoll Medical Corporation
800-EMVP-04-SNS
In Commercial Distribution
Zoll Medical Corporation
EMV+ PORTABLE VENTILATOR SYSTEM, VENTILATOR-COMPRESSOR-AIR/OXYGEN MIXER, AC POWER SUPPLY, 6' OXYGEN HOSE, 12VDC CABLE, VENTILATOR CIRCUITS, SPO2 CABLE, SPO2 SENSOR, PADDED CASE, US MILITARY,STRATEGIC NATIONAL STOCKPILE
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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CBK | Ventilator, continuous, facility use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: exactly 0 Degrees Celsius |
Handling Environment Temperature: exactly 0 Degrees Celsius |
Storage Environment Atmospheric Pressure: more than 0 KiloPascal |
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
71fb6c80-8f88-448b-8223-e2b584291fa3
July 19, 2024
2
July 08, 2024
July 19, 2024
2
July 08, 2024
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
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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