DEVICE: Oxyless (05060493650002)
Device Identifier (DI) Information
Oxyless
CK84/14-F
In Commercial Distribution
OXYLESS LIMITED
CK84/14-F
In Commercial Distribution
OXYLESS LIMITED
The Oxyless blood tubing set comprises disposable blood tubing lines intended to provide extra-corporeal access to the patient's blood during hemodialysis.
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. 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? |
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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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150304 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 34 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 146 Milliliter |
Device Record Status
e3aae127-4699-4242-bcfd-0ddce3320c1f
June 07, 2019
4
October 24, 2016
June 07, 2019
4
October 24, 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 |
---|---|---|---|---|---|
15060493650009 | 15 | 05060493650002 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined