DEVICE: Oxus Refurbished Sieve Bed (00867460000120)

Device Identifier (DI) Information

Oxus Refurbished Sieve Bed
RS-07001/RS-07002
In Commercial Distribution

OXUS AMERICA, INC.
00867460000120
GS1

1
962894098 *Terms of Use
Inogen One G3 Replacement Sieve Beds
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAW Generator, Oxygen, Portable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K211056 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

02f09c09-57e4-4ed8-b367-eb64ee2688bf
June 28, 2023
1
June 20, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No
No CLOSE

Customer Contact

[?]
2487090490
rlenarcic@oxusamerica.com
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