DEVICE: VORTRAN Medical Air Compressor (10637320081005)
Device Identifier (DI) Information
VORTRAN Medical Air Compressor
8100
In Commercial Distribution
8100
VORTRAN MEDICAL TECHNOLOGY 1, INC
8100
In Commercial Distribution
8100
VORTRAN MEDICAL TECHNOLOGY 1, INC
The VORTRAN Medical Air Compressor is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital uses. It is capable of servicing nebulizer and humidifiers to product particle aerosol mist.
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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31253 | Medical device air compressor |
A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.
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FDA Product Code
[?]Product Code | Product Code Name |
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BTI | Compressor, Air, Portable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K072634 | 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
2ab63847-dfe6-40f4-8645-bab4b0145342
July 06, 2018
3
November 30, 2017
July 06, 2018
3
November 30, 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
[?]
916-648-8460
vyang@vortran.com
vyang@vortran.com