DEVICE: AWS (05055273206982)

Device Identifier (DI) Information

AWS
WS3853
In Commercial Distribution
WS3853
RANDOX LABORATORIES LIMITED
05055273206982
GS1

1
227530649 *Terms of Use
This product should be used in conjunction with RX SERIES reagents to clean probes and cuvettes.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Wash/cleaning solution IVD, automated/semi-automated system A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.
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FDA Product Code

[?]
Product Code Product Code Name
JJF Analyzer, Chemistry, Micro, For Clinical Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K024014 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius
Special Storage Condition, Specify: Once opened the reagent is stable for 1 month on board the analyser at approximately +10ºC
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8b5a75ee-77ab-4e5a-9af7-60257dfb1ee2
July 06, 2018
3
September 26, 2016
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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
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+44289445170
technical.services@randox.com
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