DEVICE: MARK 5 NUVO LITE3 (00038214000073)
Device Identifier (DI) Information
MARK 5 NUVO LITE3
935UK
In Commercial Distribution
935UK
NIDEK MEDICAL PRODUCTS, INC.
935UK
In Commercial Distribution
935UK
NIDEK MEDICAL PRODUCTS, INC.
230V/50HZ OCSI OXYGEN CONCENTRATOR - UK PLUG
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
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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? |
---|---|---|---|---|
12873 | Stationary oxygen concentrator |
A stationary 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 typically wheeled but is designed to be placed in one location, e.g., an institution or a home setting.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAW | Generator, Oxygen, Portable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123738 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Atmospheric Pressure: between 64 and 101 KiloPascal |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
65bed8bc-1927-4e22-9d9d-c7d06512c6cf
July 06, 2018
3
August 15, 2016
July 06, 2018
3
August 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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
[?]
800-822-9255
info@nidekmedical.com
info@nidekmedical.com