DEVICE: Oxyless (05060493650002)

Device Identifier (DI) Information

Oxyless
CK84/14-F
In Commercial Distribution

OXYLESS LIMITED
05060493650002
GS1

1
218635156 *Terms of Use
The Oxyless blood tubing set comprises disposable blood tubing lines intended to provide extra-corporeal access to the patient's blood during hemodialysis.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34999 Haemodialysis blood tubing set, single-use
A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150304 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 34 and 140 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Total Volume: 146 Milliliter
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Device Record Status

e3aae127-4699-4242-bcfd-0ddce3320c1f
June 07, 2019
4
October 24, 2016
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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
15060493650009 15 05060493650002 In Commercial Distribution Box
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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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Yes
No
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Yes
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Customer Contact

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No Customer Contact currently defined
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