DEVICE: Oxyless (05060493650002)

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Device Identifier (DI) Information

Oxyless
CK84/14-F

OXYLESS LIMITED
05060493650002
GS1
1
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
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Haemodialysis tubing set, single-use A collection of sterile items intended for the administration of haemodialysis. It will typically consist of a collection of tubing segments and, e.g., connectors or clamps, required to transport blood or other fluids from a patient's vascular access device to the appropriate dialyser (haemodialyser) unit for processing. 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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Sterilization

Yes
No
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 Status

In Commercial Distribution
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
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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